- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05832567
Mechanisms of Open and Hidden Placebo in Stroke Recovery
December 15, 2023 updated by: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
This trial aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects thus providing a novel mechanism to explain placebo effects that can be used to ultimately enhance stroke rehabilitation therapies.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Placebo effect leads to significant effects on brain excitability and connectivity, ultimately influencing clinical outcomes, including motor learning in stroke.
This trial will provide critical mechanistic data to improve the understanding of placebo in stroke clinical trials, as to solve methodological and ethical dilemma in research designs, and to improve its clinical outcomes.
It aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects.
For this purpose, the investigators plan to recruit 56 chronic stroke participants, that will be randomized using blocked randomization in a 2:2:2:1 proportion to one of the following groups, respectively: 1) open placebo (OP) alone (16 subjects); 2) sham rTMS alone (16 subjects); 3) no intervention (16 subjects); or 4) active rTMS alone (8 subjects).
All four groups will undergo 2 weeks of daily intervention visits (10 sessions).
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Felipe Fregni, MD, PhD, MPH
- Phone Number: 6179526156
- Email: fregni.felipe@mgh.harvard.edu
Study Contact Backup
- Name: Elly Pichardo, MD
- Phone Number: 6179526154
- Email: epichardo@partners.org
Study Locations
-
-
Massachusetts
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Cambridge, Massachusetts, United States, 02138
- Recruiting
- Spaulding Hospital Cambridge
-
Contact:
- Elly Pichardo, MD
- Phone Number: 617-952-6158
- Email: epichardo@partners.org
-
Principal Investigator:
- Felipe Fregni, MD, PhD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults with hemiparesis due to chronic stroke
- Stroke duration of 6 months or more
- Fugl-Meyer scale upper extremity motor assessment score of > 11 and ≤ 56
- Pre-stroke disability (defined as a score of < 3 on the Modified Rankin Scale)
- Age 18 or older
Exclusion Criteria:
- Stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased EEG power in the prefrontal cortex
- Unable to understand instructions
- TMS contraindications: electronic hardware in close contact to the discharging coil such as cochlear implant, internal pulse generator or medical pump
- Concurrent unstable medical conditions
- A score of 24 or higher on the Hamilton Depression Rating Scale (HDRS)
- Joint or paretic extremity pain likely to interfere with assessments
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active rTMS
The participant will receive a session of low frequency rTMS to the contralesional primary motor cortex.
Low frequency rTMS stimulation will be applied according to the following parameter: intensity of 80% MT (intensity could be adjusted if not comfortable to the subject), frequency of 1 Hz, 1200 pulses as a single, continuous train lasting 20 minutes.
|
Subjects will undergo repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
|
Sham Comparator: Sham rTMS
The investigators will place the coil in the same location, usually used for the active stimulation with the same stimulation parameters.
However, the investigators will replace the active coil with a sham coil to ensure no stimulation is provided.
|
Subjects will undergo sham repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
|
Placebo Comparator: Open Placebo
The open placebo will consist of typical prescription medicine bottle of placebo pills with a label clearly marked "placebo pills" "take 2 pills twice daily."
The placebo pills are made from Microcrystalline Cellulose.
|
The open placebo will consist of an inactive substance pill commonly used in clinical trials and given to the subject in a regular pill dispenser.
|
No Intervention: No Intervention
It consists of treatment-as-usual group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electroencephalography (EEG): Frontal alpha asymmetry
Time Frame: Change from 2 weeks to baseline
|
The FAA score will be calculated by subtracting the natural log-transformed alpha power in the left frontal region (F3, F7, Fp1) from the natural log-transformed power in the right frontal region (F4, F8, Fp2).
|
Change from 2 weeks to baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer motor scale (FM)
Time Frame: Change from 2 weeks to baseline
|
The investigators will use this tool for motor function after stroke.
It is valid, responsive to change, and widely used for motor function and recovery assessment in stroke patients.
Items are scored on a 3-point ordinal scale, being 0 the lowest and 2 the highest value.
A higher score means a better outcome.
|
Change from 2 weeks to baseline
|
Premotor-M1 (PM-M1) connectivity
Time Frame: Change from 2 weeks to baseline
|
For the PM-M1 connectivity computation, the investigators will calculate the spectral coherence score, which indicates the functional connectivity in brain activity between two cortical regions and is calculated as a function of frequency.
|
Change from 2 weeks to baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital/Harvard Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
April 24, 2023
First Posted (Actual)
April 27, 2023
Study Record Updates
Last Update Posted (Estimated)
December 21, 2023
Last Update Submitted That Met QC Criteria
December 15, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023P000884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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