StrokeNCT05866003
tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
A study testing Active conventional tDCS montage plus CCFES, Active unconventional tDCS montage plus CCFES and CCFES with Occupational Therapy in people with Stroke and Upper Extremity Paresis, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Hemiplegia
- What is being tested?
- Active conventional tDCS montage plus CCFES, Active unconventional tDCS montage plus CCFES and CCFES with Occupational Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to Apr 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 and ≤ 90
- ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
- Able to follow 3-stage command
- Able to 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
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- Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
- Medically stable
- ≥ 10° finger and wrist extension
- Skin intact on hemiparetic arm, hand and scalp
- Muscle contraction can be elicited with Transcranial Magnetic Stimulation
- Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
- Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
- While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
Who cannot join
- Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
- Uncontrolled seizure disorder
- Use of seizure lowering threshold medications and the discretion of the study physician
- Cardiac pacemaker or other implanted electronic device
- Pregnant
- IM Botox injections in any UE muscle in the last 3 months
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- Insensate arm, forearm, or hand
- Deficits in communication that interfere with reasonable study participation
- 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)
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
Amy Friedl, MS, OTR/L, 216-957-3598, strokeresearch@metrohealth.org
David A Cunningham, PhD, 216-957-3349, dxc536@case.edu
About this study
Official title: tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement.
The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.
Read the detailed description
This study is a randomized clinical trail (RCT) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tDCS), 2) unconventional tDCS, or 3) sham tDCS during contralaterally controlled functional electrical stimulation mediated occupational therapy. The treatment will last 12 weeks and be followed by a 6-month follow-up period. Assessors, therapists and participants will be blinded to which tDCS treatment is received. This will be the first RCT of tDCS + CCFES.
- Conditions
- Stroke, Upper Extremity Paresis, Hemiplegia
- Being tested
- Active conventional tDCS montage plus CCFES, Active unconventional tDCS montage plus CCFES, Sham tDCS plus CCFES, CCFES with Occupational Therapy
- Keywords
- Stroke, Rehabilitation, Therapy, Electrical Stimulation, Brain stimulation, Hand, CCFES, Motor Cortex, TMS, Motor Recovery, Central Nervous System, CVA, Upper Limb
- Medical subject headings
- Stroke, Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active conventional tDCS montage plus CCFESDevice
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, 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.
Active unconventional tDCS montage plus CCFESDevice
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, 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.
Sham tDCS plus CCFESDevice
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 can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator.
CCFES with Occupational TherapyBehavioural
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 can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator. During the lab visits, all participants will use CCFES to assist hand opening during occupational therapy task practice.
| Study group | Role | What they receive |
|---|---|---|
| Active conventional tDCS plus CCFES | Active comparator | The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice. Receives: Device: Active conventional tDCS montage plus CCFES; Behavioral: CCFES with Occupational Therapy |
| Active unconventional tDCS plus CCFES | Active comparator | The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice. Receives: Device: Active unconventional tDCS montage plus CCFES; Behavioral: CCFES with Occupational Therapy |
| Sham tDCS plus CCFES | Sham comparator | The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice. Receives: Device: Sham tDCS plus CCFES; Behavioral: CCFES with Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Blocks Test (BBT)
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
Measured: Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Secondary outcomes (1)
Upper Extremity Fugl-Meyer Assessment (UEFM).
The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment
Measured: Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Jul 2023
- Primary completionApr 2028 (estimated)
- Study completionApr 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 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 and Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866003
- Sponsor's protocol ID
- STUDY00000229
- Status last verified
- Sep 2025
- First submitted
- 14 Apr 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
- ClinicalTrials.gov ID
- NCT05866003
- Acronym / sponsor ID
- STUDY00000229
- Conditions
- Stroke, Upper Extremity Paresis, Hemiplegia
- Keywords
- Stroke, Rehabilitation, Therapy, Electrical Stimulation, Brain stimulation, Hand, CCFES, Motor Cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 May 2023 (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.
After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement.
The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.
Detailed description
This study is a randomized clinical trail (RCT) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tDCS), 2) unconventional tDCS, or 3) sham tDCS during contralaterally controlled functional electrical stimulation mediated occupational therapy. The treatment will last 12 weeks and be followed by a 6-month follow-up period. Assessors, therapists and participants will be blinded to which tDCS treatment is received. This will be the first RCT of tDCS + CCFES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active conventional tDCS plus CCFES | Active comparator | Device: Active conventional tDCS montage plus CCFES, Behavioral: CCFES with Occupational TherapyThe conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice. |
| Active unconventional tDCS plus CCFES | Active comparator | Device: Active unconventional tDCS montage plus CCFES, Behavioral: CCFES with Occupational TherapyThe unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice. |
| Sham tDCS plus CCFES | Sham comparator | Device: Sham tDCS plus CCFES, Behavioral: CCFES with Occupational TherapyThe sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 21 and ≤ 90
- ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
- Able to follow 3-stage command
- Able to remember 2 of 3 items after 30 minutes
- Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
Key exclusion criteria (11 listed)
- Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
- Uncontrolled seizure disorder
- Use of seizure lowering threshold medications and the discretion of the study physician
- Cardiac pacemaker or other implanted electronic device
- 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 |
|---|---|---|
| Active conventional tDCS montage plus CCFEStDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, 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. | Device | Active conventional tDCS plus CCFES |
| Active unconventional tDCS montage plus CCFEStDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, 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. | Device | Active unconventional tDCS plus CCFES |
| Sham tDCS plus CCFESAn 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 can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator. | Device | Sham tDCS plus CCFES |
| CCFES with Occupational TherapyAn 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 can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator. During the lab visits, all participants will use CCFES to assist hand opening during occupational therapy task practice. | Behavioural | Active conventional tDCS plus CCFES, Active unconventional tDCS plus CCFES, Sham tDCS plus CCFES |
Primary outcome
Box and Blocks Test (BBT)
Time frame: Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
1 secondary outcome
Upper Extremity Fugl-Meyer Assessment (UEFM).
Time frame: Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
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: No
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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 and Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active conventional tDCS montage plus CCFES, Active unconventional tDCS montage plus CCFES and CCFES with Occupational Therapy in people with Stroke and Upper Extremity Paresis, 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 14 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 Amy Friedl, MS,OTR/L (216-957-3598, strokeresearch@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Blocks Test (BBT) (time frame: Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks). 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.