tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
1 other identifier
interventional
63
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jul 2023
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
May 19, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
September 29, 2025
September 1, 2025
4.8 years
April 14, 2023
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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).
Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Other Outcomes (1)
Neurophysiologic Assessments
Change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Study Arms (3)
Active conventional tDCS plus CCFES
ACTIVE COMPARATORThe 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 COMPARATORThe 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 COMPARATORThe 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Cunningham, PhD
MetroHealth Medical Center and Case Western Reserve University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 14, 2023
First Posted
May 19, 2023
Study Start
July 1, 2023
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share