StrokeNCT03857529
Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
A study testing transcranial direct current stimulation and electrical stimulator in people with Stroke and Rehabilitation, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Rehabilitation, Hand
- What is being tested?
- transcranial direct current stimulation and electrical stimulator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
- Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
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- Medically stable
- ≥ 10° finger extension
- Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of
- ≥1 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
- Skin intact on hemiparetic arm, hand and scalp
- While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
- No significant visual or hearing impairment
Who cannot join
- 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
- Pregnant
- Intramuscular botox injections in any upper extremity muscle in the last 3 months
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- Insensate arm, forearm, or hand
- Severely impaired cognition and communication
- Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
- Severe shoulder or hand pain (unable to position hand in the workspace without pain)
- Metal implant in the head
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
David A Cunningham, PhD
About this study
Official title: Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study
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.
- Conditions
- Stroke, Rehabilitation, Hand
- Being tested
- transcranial direct current stimulation and electrical stimulator
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation and electrical stimulatorDevice
Contralaterally 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.
| Study group | Role | What they receive |
|---|---|---|
| conventional tDCS concurrent with CCFES | Experimental | tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere Receives: Device: transcranial direct current stimulation and electrical stimulator |
| unconventional tDCS concurrent with CCFES | Experimental | tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere Receives: Device: transcranial direct current stimulation and electrical stimulator |
| conventional tDCS preceding CCFES | Experimental | tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere Receives: Device: transcranial direct current stimulation and electrical stimulator |
| unconventional tDCS preceding CCFES | Experimental | tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere Receives: Device: transcranial direct current stimulation and electrical stimulator |
| sham tDCS with CCFES | Sham comparator | sham tDCS preceding and concurrent with CCFES Receives: Device: transcranial direct current stimulation and electrical stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticospinal Excitability
Change in corticospinal excitability will be measured with transcranial magnetic stimulation
Measured: up to one hour post intervention
Reaction Time
Change in reaction time will be assessed with visual and auditory cues.
Measured: up to one hour post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Cunningham, MetroHealth Medical Center
- Investigators
- David A Cunningham, PhD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857529
- Sponsor's protocol ID
- IRB18-00197
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2019
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and results will be made available by request
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study
- ClinicalTrials.gov ID
- NCT03857529
- Acronym / sponsor ID
- IRB18-00197
- Conditions
- Stroke, Rehabilitation, Hand
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| conventional tDCS concurrent with CCFES | Experimental | Device: transcranial direct current stimulation and electrical stimulatortDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere |
| unconventional tDCS concurrent with CCFES | Experimental | Device: transcranial direct current stimulation and electrical stimulatortDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere |
| conventional tDCS preceding CCFES | Experimental | Device: transcranial direct current stimulation and electrical stimulatortDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere |
| unconventional tDCS preceding CCFES | Experimental | Device: transcranial direct current stimulation and electrical stimulatortDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere |
| sham tDCS with CCFES | Sham comparator | Device: transcranial direct current stimulation and electrical stimulatorsham tDCS preceding and concurrent with CCFES |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
Key exclusion criteria (11 listed)
- 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
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation and electrical stimulatorContralaterally 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. | Device | conventional tDCS concurrent with CCFES, conventional tDCS preceding CCFES, sham tDCS with CCFES, unconventional tDCS concurrent with CCFES, unconventional tDCS preceding CCFES |
Primary outcome
Corticospinal Excitability
Time frame: up to one hour post intervention
Change in corticospinal excitability will be measured with transcranial magnetic stimulation
Reaction Time
Time frame: up to one hour post intervention
Change in reaction time will be assessed with visual and auditory cues.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Yes. Data and results will be made available by request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David A Cunningham, PhD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and electrical stimulator in people with Stroke and Rehabilitation, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David A Cunningham, PhD ((216) 957-3349, Dxc536@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticospinal Excitability (time frame: up to one hour post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.