Clinical Studies for Anesthesia, Critical Care & Pain Medicine

Title: Imaging Biomarkers of Glymphatic Function in Patients with Migraine
Brief Title: Glymphatic MRI
Brief Summary: The main goal is to determine whether glymphatic imaging biomarkers are altered in migraine patients (compared to healthy controls), and whether those markers differ in chronic vs. episodic migraine patients. The study activities include a screening visit, at which you will answer some questions about your migraines (if you have a diagnosis of migraines), and an MRI scan.
For info regarding 2025P000195 please contact Narjes Jaafar at njaafar@bidmc.harvard.edu
 
Title: Investigating Changes in Anxiety, Sleep Duration and Quality after Shoonya Meditation Practice
Brief Title: RESET
Brief Summary: This study aims to investigate the effects of Shoonya Meditation (taught by the Isha Foundation) on sleep, anxiety, and stress through validated surveys, and sleep data. The control group will consist of individuals who have learned and practice Shambhavi Mahamudra Kriya, also offered by the Isha Foundation.
For info regarding 2024P000521 please contact Alex-Maree Roberts at amrobert@bidmc.harvard.edu
 
Title: Sleep, Cognition, and Pain bundle vs ERAS-cardiac [enhanced recovery after cardiac surgery] for postoperative delirium (POD)
Brief Title: SCOPE
Brief Summary: Sleep disturbances, cognitive reserve, and continuing pain and inflammation are other risk factors contributing to delirium (confusion and agitation) and neurocognitive decline (in the long term) following heart surgery. Investigators aim to test a bundle of sleep optimization, cognitive exercise before surgery, and extended pain relief for 48 hours with intravenous acetaminophen combined with enhanced recovery after surgery protocols (SCOPE bundle). SCOPE will fill significant gaps in evidence by testing the value of a patient and care-provider-focused intervention that can potentially minimize POD and improve outcomes (cognitive & physical function, sleep quality, pain, depression or anxiety, and survival) important to patients and families. The SCOPE trial will address many heart surgery outcome-related questions commonly asked by patients: What can I do to reduce my chances of developing confusion, hallucinations, or delirium after surgery? How can I best prepare before surgery to improve my long-term health and avoid disability? Are there exercises I can participate in that improve my sleep, pain, and mood after surgery? Intellectual pursuits, physical activity, and social interactions support cognitive reserve, while poor health, poor sleep hygiene, poor nutrition, and mental health disease can diminish reserve. Various interventions with different intensities and timing to augment cognitive reserve have been associated with positive outcomes on neuropsychological testing. Adaptive video gaming for as little as 10 hours leads to the maintenance of independence in activities of daily living and sustained improvements in speed of processing, attention, and working memory in older people. Likely through the increased cognitive reserve, perioperative brain exercise aims to protect against morbid cognitive recovery after surgery. Sleep is vital for memory and cognitive function. Poor sleep traits in older adults that are potentially modifiable, including short/long duration, daytime napping, and associated sleepiness, led to an almost 2-fold increase in delirium risk. Patients will complete an evidence-based course on healthy sleep habits and will complete guided exercises designed to restructure behaviors and thinking. They are encouraged to follow a set of recommendations to improve their sleep (e.g., optimal sleep duration, advice for habits such as daytime napping, maintaining a regular sleep schedule, avoiding caffeine, regular daylight exposure, dimming lights or electronics and relaxation and thought exercises for optimal sleep); many of these sleep behaviors have been strongly linked to increased risk for cognitive decline. Investigators propose that sleep optimization before AND after (an established best practice sleep bundle) surgical insult will contribute to cognitive reserve leading to decreased delirium risk and key patient-centered outcomes (postoperative sleep, pain, cognition, mood, and survival). Inadequate pain relief and opioids are both risk factors for delirium. Surgery on the chest is a significant pain source. Approximately 30-75% of patients suffer from moderate to severe pain in the postoperative period. Almost half of the patients have severe pain at rest, and three-quarters have severe pain during coughing and movement. Pain and inflammation are closely biochemically linked. Sleep, brain exercise, and adequate pain control with opioid-sparing can be additive or synergistic interventions to prevent delirium following heart surgery. Investigators propose three specific aims by conducting a 1:1 randomized controlled trial in 406 heart surgery patients 60 or older undergoing heart surgery. They will be administered perioperative sleep optimization, brain exercise training, and intravenous acetaminophen over 48 hours. A trained expert will administer the sleep and cognitive exercise protocols at least two weeks before surgery. This expert will handhold the patients for two weeks until the surgery. Thus, the gains made before surgery with better sleep quality and improved brain reserve will be sustained with postoperative pain control to lower the ongoing inflammation. Through this trial, investigators will evaluate if the SCOPE bundle can reduce 1) in-hospital delirium, 2) long-term (one, six, and twelve months) cognitive, physical, and self-care function, and 3) barriers to implementation of this bundle. Currently, no options are routinely available to patients to optimize their sleep and cognition before cardiac surgery. The proposed research is significant because it will be the first to test the bundled behavioral intervention approach (sleep optimization, brain exercise) before surgery with extended, scheduled pain management with non-opioids following surgery. The SCOPE trial will yield relevant and immediately actionable data to improve care for over 900,000 adults in the U.S. each year.
For info regarding 2024P000520 please contact Balachundhar Subramaniam at 617-754-2721 or bsubrama@bidmc.harvard.edu
 
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Episodic Migraine in Adult Participants
Brief Title: E-BEOND
Brief Summary: The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine. A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches. Migraines are caused by a series of events which cause the brain to get stimulated / activated, which results in the release of chemicals that cause pain. Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers. The study will consist of 3 periods: 1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit. 2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders. The injections will contain either a dose "A" or a dose ''B'' of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied). Participants will make 4 visits to the clinic in person and have 4 remote (online) visits. 3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B"). There will be 3 in person visits and 4 remote visits. Participants will need to complete an e-diary and questionnaires throughout the study. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. The total study duration for a participant will be up to 60 weeks (approx. 14 months).
For info regarding 2024P000238 please contact Sait Ashina at 617-667-6000 or sashina@bidmc.harvard.edu
 
Title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport for the Prevention of Chronic Migraine in Adult Participants
Brief Title: C-BEOND
Brief Summary: The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing chronic migraine. A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Chronic migraine is defined as having at least 15 days of headache a month with at least 8 of those days being migraine headache days. Migraines are caused by a series of events which cause the brain to get stimulated/activated, which results in the release of chemicals that cause pain. Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers. The study will consist of 3 periods: 1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit. 2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders. The injections will contain either a dose "A" or dose "B" of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied). Participants will make 4 visits to the clinic in person and have 4 remote (online) visits. 3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B"). There will be 3 in person visits and 4 remote visits. Participants will need to complete an e-diary and questionnaires throughout the study. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. The total study duration for a participant will be up to 60 weeks (approx. 14 months).
For info regarding 2024P000220 please contact Sait Ashina at 617-667-6000 or sashina@bidmc.harvard.edu
 
Title: CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State - CERBERUS
Brief Title: CERBERUS
Brief Summary: The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question[s] it aims to answer are: - Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor? - How much does this optimal blood pressure level vary between patients? Participants will be asked to: - Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team. - They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.
For info regarding 2023P000843 please contact Samir Kendale at skendale@bidmc.harvard.edu
 
Title: PREVENT VILI: Prevention of Ventilator Induced Lung Injury
Brief Title: PREVENT VILI: a multicenter RCT of ventilation for ARDS
Brief Summary: The goal of this interventional study is to compare standard mechanical ventilation to a lung-stress oriented ventilation strategy in patients with Acute Respiratory Distress Syndrome (ARDS). Participants will be ventilated according to one of two different strategies. The main question the study hopes to answer is whether the personalized ventilation strategy helps improve survival.
For info regarding 2023P000682 please contact Daniel Talmor at 617-754-3257 or dtalmor@bidmc.harvard.edu
 
Title: Cognitive Function and Affective Regulation in Meditators
Brief Title: CALM
Brief Summary: This research is being done to assess the impact of meditation practice on cognitive function and emotional regulation. We are also looking to assess its impact on positive and negative emotions, feelings of stress, anxiety, and depression. You will be asked to complete a set of online cognitive tasks as well as a detailed survey at a singular time-point after the time of consent.
For info regarding 2023P000588 please contact Ashwin Swaminathan at 617-278-8150 or Sadhgurucenter_research@bidmc.harvard.edu
 
Title: Eyecontrol coMmunication platform for dEliRium manaGemEnt in intensive care units (EMERGE) : A Multicenter Randomized Controlled Trial
Brief Title: EMERGE
Brief Summary: The purpose of this research is to investigate whether addition of the EyeControl-Pro platform as an adjunct to standard guideline-based intensive care unit management of critically ill patients is effective in reducing delirium incidence and severity.
For info regarding 2023P000563 please contact Somnath Bose at 617-667-7600 or sbose2@bidmc.harvard.edu
 
Title: Narrow band green light effects on cortical excitability and responsivity in migraine
Brief Title: Narrow band greenlight
For info regarding 2023P000201 please contact Rami Burstein, PhD at rburstei@bidmc.harvard.edu
 
Title: BRANCH: Brain Age and Sleep Architecture in Meditators
Brief Title: BRANCH: Brain Age and Sleep Architecture in Meditators
Brief Summary: This is a single-center, cross-sectional study that will recruit approximately fifty (50) meditators and fifty controls. Individuals that have learned at least the Shambhavi Mahamudra Kriya practice and live in Massachusetts will be mailed a DREEM EEG device, and a sleepimage ring. Participants will be asked to wear the two devices while sleeping for three consecutive weekday nights (Sunday night to Thursday night) and two weekend nights (Friday and Saturday nights). While meditating during the day, participants will only wear the DREEM EEG headband. Participants will also undergo neurocognitive tests from the NIH toolbox during one virtual visit via video call. Meditators who join the study will be asked to invite a control subject to the study, matched for age and comorbidities.
For info regarding 2022P000597 please contact Sepideh Hariri, PhD at 617-667-2721 or sadhugurucenter_research@bidmc.harvard.edu
 
Title: Brain Health with Inner Engineering- Longitudinal Study of Shambhavi Mahamudra Kriya Meditation (BLISS)
Brief Title: BLISS
Brief Summary: This study will explore whether a 21-minute meditation practice called Shambhavi Mahamudra Kriya leads to changes in brain health and explore how it affects cognitive and physiological function.
For info regarding 2022P000296 please contact Sepideh Hariri at 617-278-8082 or shariri1@bidmc.harvard.edu
 
Title: Meditation and Breathing for Mental Health in Parkinson’s Disease Patients
Brief Title: Yoga for Parkinson’s
Brief Summary: This study is a waitlisted randomized controlled trial. We aim to assess the level of compliance for those learning the intervention and to evaluate the impact of the practice on neuropsychological and somatic outcomes using validated scales. Enrollment into the study will be ongoing until we are able to get a sufficient sample size as described in the "Statistical Consideration" section. Upon enrollment and randomization, surveys will be administered to both the intervention and control groups at four time-points: baseline, T2, T3, and T4, each of which are 6 weeks apart. Compliance data will be collected weekly for 12 weeks for both groups.
For info regarding 2022P000212 please contact Sadhguru Center for a Conscious Planet Study Team at SadhguruCenter_Research@bidmc.harvard.edu.
 
Title: Yogic Breathing and Guided Meditation for Long Covid Symptoms
Brief Title: Covid No Longer
Brief Summary: This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.
For info regarding 2021P000552 please contact Balachundhar Subramaniam at 617-754-2721 or bsubrama@bidmc.harvard.edu
 
Title: REST: Resilience to Sleep Deprivation and Changes in Sleep Architecture in Shoonya Meditators
Brief Title: Sleep Architecture in Shoonya Meditators
Brief Summary: This study aims to investigate the effect of a 15-minute meditation practice on sleep architecture and high-frequency Heart Rate Variability (HF-HRV), as well as cognitive performance after both a well-rested and sleep-deprived night.
For info regarding 2021P000544 please contact Akshaj Joshi at 617-278-8058 or sadhgurucenter_research@bidmc.harvard.edu
 
Title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
Brief Title: VR in the OR: TKA
Brief Summary: The objective of this study is to investigate whether the use of virtual reality (VR) during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative requirements while maintaining high levels of patient satisfaction as compared to both a music and sham VR + usual care control.
For info regarding 2020P001176 please contact Center for Anesthesia Research Excellence at vgoodspe@bidmc.harvard.edu
 
Title: Postoperative Virtual Reality (VR) for Recovery after Bariatric Surgery
Brief Title: Postoperative VR Bariatric
Brief Summary: The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could improve postoperative recovery from bariatric surgery.
For info regarding 2020P001149 please contact Center for Anesthesia Research Excellence at vgoodspe@bidmc.harvard.edu
 
Title: Comparison of Continuous Non-Invasive Arterial Blood Pressure to Invasive Arterial Blood Pressure Measurement in Pregnant Women with Placenta Accreta
Brief Title: CNAP vs IABP in pregnant women with placenta accreta
Brief Summary: The objective of this study is to investigate a technique to monitor blood pressure in women undergoing cesarean delivery with suspected placenta accreta spectrum. To achieve this objective, the investigators plan to conduct a prospective, observational study with the following aims: Specific Aim 1: Compare concordance between the systolic (SBP), diastolic (DBP), and mean arterial blood pressure (MAP) readings from the continuous non-invasive arterial blood pressure (CNAP) and IABP at several discrete points throughout the procedure Specific Aim 2: Determine the feasibility of using CNAP to aid in decision making by examining the parameters of volume responsiveness and arterial elastance at several discrete points throughout the procedure. The investigators hypothesize that the investigators can obtain similar blood pressure monitoring using CNAP as compared to the gold standard IABP in women undergoing cesarean delivery with suspected placenta accreta.
For info regarding 2020P001099 please contact John Kowalczyk at 617-667-3112 or jkowalcz@bidmc.harvard.edu
 
Title: Examining the gastric emptying halftime of water versus a carbohydrate in early labor
Brief Title: Gastric emptying in labor
Brief Summary: To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.
For info regarding 2019P001110 please contact Philip Hess at 617-667-3112 or phess@bidmc.harvard.edu
 
Title: Effects of the Orexin Receptor Antagonist Suvorexant on Sleep Architecture and Delirium in the Intensive Care Unit: a Randomized Controlled Trial
Brief Title: Suvorezant and sleep/delirium in ICU patients
Brief Summary: Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical patients recovering in the cardiac intensive care unit (ICU). The study include patients = 60 years old undergoing coronary artery bypass graft surgery (CABG), with or without valve surgery (aortic or mitral). Patients will receive either oral suvorexant or placebo for 7 nights starting the night after extubation. The primary hypothesis is that suvorexant compared with placebo decreases WASO, as measured by a specialized electroencephalogram (EEG), the SedLine monitor, during the first night in the cardiac ICU. Investigators will also assess total sleep time (TST), time to sleep onset (TSO), and postoperative delirium and delirium-free days.
For info regarding 2019P000759 please contact Center for Anesthesia Research Excellence at vgoodspe@bidmc.harvard.edu
 
Title: PANDORA: Scheduled prophylactic 6-hourly intravenous acetaminophen to prevent postoperative delirium in older cardiac surgical patients
Brief Title: PANDORA:Delirium prevention after cardiac surgery using IV
Brief Summary: Our objective is to find an effective prophylactic intervention by evaluating IV acetaminophen's impact in reducing the frequency of postoperative delirium, one of the most common and detrimental complications of cardiac surgery in older adults.
For info regarding 2019P000758 please contact Center for Anesthesia Research Excellence at vgoodspe@bidmc.harvard.edu