Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation

MetroHealth Medical Center

Status: Enrolling

Conditions: Rehabilitation; Stroke; Hand

Treatments: Device: transcranial direct current stimulation and electrical stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT03857529

IRB18-00197

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 5 patient groups

conventional tDCS concurrent with CCFES

Experimental group

Description:

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

Treatment:

Device: transcranial direct current stimulation and electrical stimulator

unconventional tDCS concurrent with CCFES

Experimental group

Description:

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

Treatment:

Device: transcranial direct current stimulation and electrical stimulator

conventional tDCS preceding CCFES

Experimental group

Description:

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

Treatment:

Device: transcranial direct current stimulation and electrical stimulator

unconventional tDCS preceding CCFES

Experimental group

Description:

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

Treatment:

Device: transcranial direct current stimulation and electrical stimulator

sham tDCS with CCFES

Sham Comparator group

Description:

sham tDCS preceding and concurrent with CCFES

Treatment:

Device: transcranial direct current stimulation and electrical stimulator