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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