Hemiparesis, Stroke
Conditions
Keywords
stroke, placebo
Brief 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.
Detailed 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 be randomized using blocked randomization in a 2:2:2:1 proportion to one of the following groups, respectively: 1) open placebo (OP) alone (16 subjects); 2) sham rTMS alone (16 subjects); 3) no intervention (16 subjects); or 4) active rTMS alone (8 subjects). All four groups will undergo 2 weeks of daily intervention visits (10 sessions).
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.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electroencephalography (EEG): Frontal alpha asymmetry | Change from 2 weeks to baseline | The FAA score will be calculated by subtracting the natural log-transformed alpha power in the left frontal region (F3, F7, Fp1) from the natural log-transformed power in the right frontal region (F4, F8, Fp2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer motor scale (FM) | Change from 2 weeks to baseline | The investigators will use this tool for motor function after stroke. It is valid, responsive to change, and widely used for motor function and recovery assessment in stroke patients. Items are scored on a 3-point ordinal scale, being 0 the lowest and 2 the highest value. A higher score means a better outcome. |
| Premotor-M1 (PM-M1) connectivity | Change from 2 weeks to baseline | For the PM-M1 connectivity computation, the investigators will calculate the spectral coherence score, which indicates the functional connectivity in brain activity between two cortical regions and is calculated as a function of frequency. |
Countries
United States
Contacts
CONTACTFelipe Fregni, MD, PhD, MPH
CONTACTElly Pichardo, MD
PRINCIPAL_INVESTIGATORFelipe Fregni, MD, PhD, MPH
Spaulding Rehabilitation Hospital/Harvard Medical School
Outcome results
None listed