Mechanisms of Open and Hidden Placebo in Stroke Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpaulding Rehabilitation Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with hemiparesis due to chronic stroke
Stroke duration of 6 months or more
Fugl-Meyer scale upper extremity motor assessment score of > 11 and ≤ 56
Pre-stroke disability (defined as a score of < 3 on the Modified Rankin Scale)
Disqualifiers
Stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased EEG power in the prefrontal cortex
Unable to understand instructions
TMS contraindications: electronic hardware in close contact to the discharging coil such as cochlear implant, internal pulse generator or medical pump
Concurrent unstable medical conditions
Trial design
Design model
Parallel
Treatments tested in this trial
Active rTMS
DeviceSubjects will undergo repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
Sham rTMS
DeviceSubjects will undergo sham repetitive transcranial magnetic stimulation, each session lasting 20 minutes.
Open Placebo
Dietary supplementThe open placebo will consist of an inactive substance pill commonly used in clinical trials and given to the subject in a regular pill dispenser.
Treatment groups
56 Participants
are divided into 4 treatment groupsGroup A: Active rTMSActive comparator 1 intervention
Group B: Sham rTMSSham comparator 1 intervention
Group C: Open PlaceboPlacebo comparator 1 intervention
Group D: No InterventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Electroencephalography (EEG): Frontal alpha asymmetry
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).
Time frame
Change from 2 weeks to baselineSecondary outcomes
1
Fugl-Meyer motor scale (FM)
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.
Time frame
Change from 2 weeks to baseline2
Premotor-M1 (PM-M1) connectivity
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.
Time frame
Change from 2 weeks to baselineSponsors and contacts
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Source ClinicalTrials.gov