Mechanisms of Open and Hidden Placebo in Stroke Recovery

Launched by SPAULDING REHABILITATION HOSPITAL · Apr 24, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Mechanisms of Open and Hidden Placebo in Stroke Recovery," is exploring how placebos (which are treatments without active ingredients) can affect recovery after a stroke. Researchers want to understand if there are specific brain responses to open placebos (where patients know they are getting a placebo) and hidden placebos (where they don’t know). The goal is to find ways to use these findings to improve rehabilitation therapies for people recovering from a stroke.

To participate in this study, you need to be an adult aged 18 or older who has hemiparesis (weakness on one side of the body) due to a stroke that happened at least six months ago. You should also have a specific level of motor function and not have severe depression or other health issues that could interfere with the study. If you join, you can expect to take part in assessments that will help researchers learn more about how placebos impact recovery. Your participation could contribute to developing better treatments for stroke recovery in the future.

Gender

ALL

Eligibility criteria

• 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