Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMetroHealth Medical Center
About this trial
This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21
≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
Disqualifiers
Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis).
Uncontrolled seizure disorder
Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
Cardiac pacemaker or other implanted electronic device and/or stent
Trial design
Design model
Crossover
Treatments tested in this trial
transcranial direct current stimulation and electrical stimulator
DeviceContralaterally Controlled Functional Electrical Stimulation: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.
Treatment groups
15 Participants
are divided into 5 treatment groupsGroup A: conventional tDCS concurrent with CCFESExperimental treatment 1 intervention
Group B: unconventional tDCS concurrent with CCFESExperimental treatment 1 intervention
Group C: conventional tDCS preceding CCFESExperimental treatment 1 intervention
Group D: unconventional tDCS preceding CCFESExperimental treatment 1 intervention
Group E: sham tDCS with CCFESSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Corticospinal Excitability
Change in corticospinal excitability will be measured with transcranial magnetic stimulation
Time frame
up to one hour post intervention2
Reaction Time
Change in reaction time will be assessed with visual and auditory cues.
Time frame
up to one hour post interventionSponsors and contacts
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Source ClinicalTrials.gov