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

Sponsor

MetroHealth Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05866003

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Upper Extremity Paresis Hemiplegia	Device: Active conventional tDCS montage plus CCFES Device: Active unconventional tDCS montage plus CCFES Device: Sham tDCS plus CCFES Behavioral: CCFES with Occupational Therapy	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2028

Anticipated Study Completion Date :

Apr 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active conventional tDCS plus CCFES 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.	Device: Active conventional tDCS montage plus CCFES 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. Behavioral: CCFES with Occupational Therapy 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.
Active Comparator: Active unconventional tDCS plus CCFES 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.	Device: Active unconventional tDCS montage plus CCFES 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. Behavioral: CCFES with Occupational Therapy 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.
Sham Comparator: Sham tDCS plus CCFES 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.	Device: Sham tDCS plus CCFES 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. Behavioral: CCFES with Occupational Therapy 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.

Arm

Intervention/Treatment

Active Comparator: Active conventional tDCS plus CCFES

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.

Device: Active conventional tDCS montage plus CCFES

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.

Behavioral: CCFES with Occupational Therapy

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.

Active Comparator: Active unconventional tDCS plus CCFES

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.

Device: Active unconventional tDCS montage plus CCFES

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.

Behavioral: CCFES with Occupational Therapy

Sham Comparator: Sham tDCS plus CCFES

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.

Device: Sham tDCS plus CCFES

Behavioral: CCFES with Occupational Therapy

Outcome Measures

Primary Outcome Measures

Box and Blocks Test (BBT) [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.

Secondary Outcome Measures

Upper Extremity Fugl-Meyer Assessment (UEFM). [Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks]
The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment

Other Outcome Measures

Neurophysiologic Assessments [Change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks]
Neurophysiologic assessments will be performed using TMS. Measures of excitability and inhibition will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 21 and ≤ 90
≥ 6 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.

Exclusion Criteria:

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)