Investigating the effects of placebo on stroke recovery
Mechanisms of Open and Hidden Placebo in Stroke Recovery
NA · Spaulding Rehabilitation Hospital · NCT05832567
This study is testing how different types of placebo treatments can help people recovering from a stroke feel better and improve their brain function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital (other) |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT05832567 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with hemiparesis due to chronic stroke lasting six months or more.
Not a fit: Patients with specific contraindications to TMS or those with severe depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for stroke patients by leveraging the placebo effect.
How similar studies have performed: While the placebo effect has been studied in various contexts, this specific investigation into its neural mechanisms in stroke recovery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cambridge, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Hemiparesis, stroke, placebo