Recruiting

Non-invasive Brain Stimulation & Functional Electrical Stimulation

Sponsor:

MetroHealth Medical Center

Code:

NCT03857529

Conditions

Stroke

Rehabilitation

Hand

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulation and electrical stimulator

Study Details

Brief 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. 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

Study ID

NCT03857529

Start date

Aug 1, 2019

Status verified date

Sep, 2025

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 21
2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
3. Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
4. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
5. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
6. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
7. Medically stable
8. ≥ 10° finger extension
9. 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
10. Skin intact on hemiparetic arm, hand and scalp
11. While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
12. No significant visual or hearing impairment

Exclusion Criteria:

1. 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).
2. Uncontrolled seizure disorder
3. Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
4. Cardiac pacemaker or other implanted electronic device and/or stent
5. Pregnant
6. Intramuscular botox injections in any upper extremity muscle in the last 3 months
7. Insensate arm, forearm, or hand
8. Severely impaired cognition and communication
9. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
10. Severe shoulder or hand pain (unable to position hand in the workspace without pain)
11. Metal implant in the head

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: conventional tDCS concurrent with CCFES

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

experimental: unconventional tDCS concurrent with CCFES

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

experimental: conventional tDCS preceding CCFES

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

experimental: unconventional tDCS preceding CCFES

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

sham comparator: sham tDCS with CCFES

sham tDCS preceding and concurrent with CCFES

Interventions

transcranial direct current stimulation and electrical stimulator

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.

Primary outcome measure

  • Corticospinal Excitability [ Time Frame: up to one hour post intervention ]
  • Reaction Time [ Time Frame: up to one hour post intervention ]

Central Contacts and Locations

Central contacts

David A Cunningham, PhD

(216) 957-3349Dxc536@case.edu

Locations

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

More Information

Sponsor

MetroHealth Medical Center

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MetroHealth Medical Center on 2025-09-29.