Mechanisms of Open and Hidden Placebo in Stroke Recovery
Spaulding Rehabilitation Hospital
Summary
This trial aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects thus providing a novel mechanism to explain placebo effects that can be used to ultimately enhance stroke rehabilitation therapies.
Description
Placebo effect leads to significant effects on brain excitability and connectivity, ultimately influencing clinical outcomes, including motor learning in stroke. This trial will provide critical mechanistic data to improve the understanding of placebo in stroke clinical trials, as to solve methodological and ethical dilemma in research designs, and to improve its clinical outcomes. It aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects. For this purpose, the investigators plan to recruit 56 chronic stroke participants, that will…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, inter…
Interventions
- DeviceActive rTMS
Subjects will undergo repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
- DeviceSham rTMS
Subjects will undergo sham repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
- Dietary SupplementOpen Placebo
The open placebo will consist of an inactive substance pill commonly used in clinical trials and given to the subject in a regular pill dispenser.
Location
- Spaulding Hospital CambridgeCambridge, Massachusetts