Investigating the effects of placebo on stroke recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to explore the specific neural signatures associated with open and hidden placebo effects in individuals recovering from stroke. By examining how these placebo effects influence brain excitability and connectivity, the study seeks to enhance rehabilitation therapies for stroke patients. A total of 56 chronic stroke participants will be randomized into four groups to receive either open placebo, sham rTMS, no intervention, or active rTMS over a two-week period. The findings could provide critical insights into the role of placebo in stroke recovery and improve clinical outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults with hemiparesis due to chronic stroke
2. Stroke duration of 6 months or more
3. Fugl-Meyer scale upper extremity motor assessment score of \> 11 and ≤ 56
4. Pre-stroke disability (defined as a score of \< 3 on the Modified Rankin Scale)
5. Age 18 or older

Exclusion Criteria:

1. Stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased EEG power in the prefrontal cortex
2. Unable to understand instructions
3. TMS contraindications: electronic hardware in close contact to the discharging coil such as cochlear implant, internal pulse generator or medical pump
4. Concurrent unstable medical conditions
5. A score of 24 or higher on the Hamilton Depression Rating Scale (HDRS)
6. Joint or paretic extremity pain likely to interfere with assessments
7. Pregnancy

Where it's running

• Spaulding Hospital Cambridge
  Cambridge, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Felipe Fregni, MD, PhD, MPH — Spaulding Rehabilitation Hospital/Harvard Medical School
• Study coordinator: Felipe Fregni, MD, PhD, MPH
• Email: fregni.felipe@mgh.harvard.edu
• Phone: 6179526156

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.