Investigating the Effects of Transcranial Stimulation to Advance Stroke Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oxford
About this trial
Non-invasive brain stimulation (NIBS) has the potential to boost rehabilitation after stroke by creating a 'pro-plastic' environment, where the brain is more adaptable in response to movement (motor) training. However, responses to classical NIBS protocols are highly variable.
Movement-related changes in specific brain rhythms have previously been shown to be related to recovery of hand/arm function after a stroke. The investigators propose to use NIBS to target movement-related activity in the beta band (13-30Hz) within the motor cortical regions of the brain. The investigators will use a type of NIBS called transcranial alternating current stimulation (tACS), which uses a sinusoidally-varying electrical current where the stimulation frequency is determined to be relevant to the underlying brain rhythms of interest, and the stimulation timed to coincide with specific phases of the hand/arm movement.
The primary aim is to investigate whether beta-tACS improves upper limb movement in stroke survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to give informed consent for participation in the study.
Aged 18 years or above.
Clinical diagnosis of stroke affecting the upper limb, with sufficient ability to perform the upper limb reaching task.
At least 3 months post-stroke and discharged from inpatient care.
Disqualifiers
Inability to follow task instructions.
Other neurological condition affecting movement (e.g. Parkinson's Disease, Multiple Sclerosis).
Standard contraindications to non-invasive brain stimulation (TMS, tACS). including (but not limited to) the presence of intracranial metallic or magnetic hardware, seizures, pregnancy, and the presence of a pacemaker or other stimulators/implants.
Insufficient verbal and written English to comprehend the study and provide informed consent.
Trial design
Design model
Crossover
Treatments tested in this trial
Transcranial Alternating Current Stimulation (beta-tACS)
Other interventionThe study intervention is transcranial alternating current stimulation (tACS). The electrode montage will include one electrode positioned on the scalp over the left or right motor cortex (either C3 or C4 using the international 10-20 EEG system), depending on the location of the stroke, and a second electrode over posterior area (Pz). A low intensity of stimulation (max. 4 mA peak to peak amplitude) will be used for up to 30 minutes in total (delivered in short bouts of up to 5 seconds based on the timing of movement of the upper limb).
Transcranial Alternating Current Stimulation (sham)
Other interventionThe comparator is sham stimulation. Stimulation is delivered for a very short duration or timed in such a way relative to movement to mimic the scalp sensations of the active stimulation without delivering stimulation that would be anticipated to impact relevant brain activity rhythms.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active Stimulation (beta-tACS)Experimental treatment 1 intervention
Group B: Sham Stimulation (tACS)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Reaching Performance
Performance on the reaching task, assessed using a motion sensor as the error (deviation from the ideal path) in cubic centimeters. Higher numbers indicate worse error/reaching performance.
Time frame
From the first stimulation session to the completion of the third and final session, an average of 1 monthSecondary outcomes
1
Movement-related Brain Rhythms
Movement-related beta activity measured using electroencephalography (EEG), as power in decibels. Higher values indicate stronger (better) movement-related beta activity.
Time frame
From the first stimulation session to the completion of the third and final session, an average of 1 month2
Hand Function
Change in hand function measured with the Box and Blocks Test from pre-stimulation to post-stimulation. Box and blocks test performance is measured as the number of blocks moved with the affected hand in 1 minute, higher numbers indicate better hand function.
Time frame
From the first stimulation session to the completion of the third and final session, an average of 1 monthOther outcomes
1
Smoothness of reaching movement (peaks)
Smoothness of reaching movement assessed using a motion sensor as the number of peaks (number). Higher values indicate worse smoothness of reaching movement.
Time frame
From the first stimulation session to the completion of the third and final session, an average of 1 month2
Smoothness of reaching movement (arrest periods)
Smoothness of reaching movement assessed using a motion sensor as the time of arrest periods (seconds). Higher numbers indicate worse smoothness of movement.
Time frame
From the first stimulation session to the completion of the third and final session, an average of 1 month3
Smoothness of reaching movement (Jerk)
Smoothness of reaching movement assessed using a motion sensor as the jerk metric (time rate of change in acceleration) in centimeters per second. Lower values indicate better smoothness of reaching movement.
Time frame
From the first stimulation session to the completion of the third and final session, an average of 1 month4
Brain Structure at baseline (grey matter volume)
Brain structure measured with magnetic resonance imaging at baseline as the volume of grey matter in the motor-related areas of the ipsilesional hemisphere of the brain. Higher numbers indicate greater grey matter (brain) volume.
Time frame
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Source ClinicalTrials.gov