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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

Must not have

Stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased EEG power in the prefrontal cortex

Joint or paretic extremity pain likely to interfere with assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 2 weeks to baseline

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.

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.

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 below

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I have weakness on one side of my body due to a past stroke.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stroke affecting the front part of my brain, confirmed by EEG.

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I have joint pain that could affect my ability to participate in assessments.

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I do not have any unstable health conditions.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 2 weeks to baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Electroencephalography (EEG): Frontal alpha asymmetry

Secondary study objectives

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.

0 / 5Eligibility criteria met