tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia

MetroHealth Medical Center

Status: Enrolling

Conditions: Upper Extremity Paresis; Stroke; Hemiplegia

Treatments: Device: Sham tDCS plus CCFES; Device: Active conventional tDCS montage plus CCFES; Behavioral: CCFES with Occupational Therapy; Device: Active unconventional tDCS montage plus CCFES

Study type: Interventional

Funder types: Other

Identifiers

NCT05866003

STUDY00000229

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 estimated patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 21 and ≤ 90
2. ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
3. Able to follow 3-stage command
4. Able to remember 2 of 3 items after 30 minutes
5. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
6. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
7. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
8. Medically stable
9. ≥ 10° finger and wrist extension
10. Skin intact on hemiparetic arm, hand and scalp
11. Muscle contraction can be elicited with Transcranial Magnetic Stimulation
12. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
13. Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
14. While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.

Exclusion criteria

1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
2. Uncontrolled seizure disorder
3. Use of seizure lowering threshold medications and the discretion of the study physician
4. Cardiac pacemaker or other implanted electronic device
5. Pregnant
6. IM Botox injections in any UE muscle in the last 3 months
7. Insensate arm, forearm, or hand
8. Deficits in communication that interfere with reasonable study participation
9. Severely impaired cognition and communication
10. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
11. Severe shoulder or hand pain (unable to position hand in the workspace without pain)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups

Active conventional tDCS plus CCFES

Active Comparator group

Description:

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.

Treatment:

Behavioral: CCFES with Occupational Therapy

Device: Active conventional tDCS montage plus CCFES

Active unconventional tDCS plus CCFES

Active Comparator group

Description:

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.

Treatment:

Device: Active unconventional tDCS montage plus CCFES

Behavioral: CCFES with Occupational Therapy

Sham tDCS plus CCFES

Sham Comparator group

Description:

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.

Treatment:

Behavioral: CCFES with Occupational Therapy

Device: Sham tDCS plus CCFES