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Procedure
Placebo Effects for Stroke Recovery
N/A
Recruiting
Led By Felipe Fregni, MD, PhD, MPH
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults with hemiparesis due to chronic stroke
Age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 2 weeks to baseline
Awards & highlights
Study Summary
This trial will explore how the brain responds to placebo, which could help improve stroke recovery therapies.
Who is the study for?
This trial is for adults over 18 who've had a stroke at least 6 months ago, resulting in one-sided weakness but still have some arm movement. They should not be severely disabled before the stroke and must understand instructions. People with joint pain, certain brain injuries from their stroke, pregnancy, unstable health conditions or electronic implants near the brain can't join.Check my eligibility
What is being tested?
The study tests if different types of placebo (openly given as a placebo or disguised) and active repetitive Transcranial Magnetic Stimulation (rTMS), which is a non-invasive brain stimulation technique, affect recovery in chronic stroke patients differently.See study design
What are the potential side effects?
Active rTMS might cause discomfort at the stimulation site, headaches or lightheadedness. There's also a small risk of seizure. The placebos are unlikely to cause direct side effects since they do not have an active component.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have weakness on one side of my body due to a past stroke.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from 2 weeks to baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 2 weeks to baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Electroencephalography (EEG): Frontal alpha asymmetry
Secondary outcome measures
Fugl-Meyer motor scale (FM)
Premotor-M1 (PM-M1) connectivity
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: No InterventionActive Control1 Intervention
It consists of treatment-as-usual group.
Group II: Active rTMSActive Control1 Intervention
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.
Group III: Sham rTMSPlacebo Group1 Intervention
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.
Group IV: Open PlaceboPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
135 Previous Clinical Trials
10,999 Total Patients Enrolled
25 Trials studying Stroke
953 Patients Enrolled for Stroke
Felipe Fregni, MD, PhD, MPHPrincipal InvestigatorSpaulding Rehabilitation Hospital/Harvard Medical School
13 Previous Clinical Trials
552 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a stroke affecting the front part of my brain, confirmed by EEG.I had a stroke more than 6 months ago.You had difficulty with daily activities before the stroke.Your upper arm and hand movement score on the Fugl-Meyer scale is between 11 and 56.I have joint pain that could affect my ability to participate in assessments.I have weakness on one side of my body due to a past stroke.I do not have any unstable health conditions.I am 18 years old or older.You have electronic devices near the area where the treatment will be done, like a cochlear implant or a medical pump.Your score on the Hamilton Depression Rating Scale (HDRS) is 24 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Sham rTMS
- Group 2: Open Placebo
- Group 3: No Intervention
- Group 4: Active rTMS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment in progress and open for recruitment to participants?
"According to clinicaltrials.gov, the trial has concluded recruitment and is no longer searching for patients. Initially posted on July 1st 2023, this study was last revised on April 24th 2023. Fortunately, there are still 1089 other trials actively enrolling volunteers at this time."
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