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

ConditionsStroke Upper Extremity Paresis Hemiplegia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-90

SponsorMetroHealth Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Active conventional tDCS montage plus CCFES
Device
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.
Active unconventional tDCS montage plus CCFES
Device
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.
Sham tDCS plus CCFES
Device
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.
CCFES with Occupational Therapy
Behavioral
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.

Treatment groups

63 Participants

are divided into 3 treatment groups

Group A: Active conventional tDCS plus CCFESActive comparator 2 interventions

Group B: Active unconventional tDCS plus CCFESActive comparator 2 interventions

Group C: Sham tDCS plus CCFESSham comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Secondary outcomes

Upper Extremity Fugl-Meyer Assessment (UEFM).

The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment

Time frame

Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Other outcomes

Neurophysiologic Assessments

Neurophysiologic assessments will be performed using TMS. Measures of excitability and inhibition will be measured.

Time frame

Change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MetroHealth Medical Center

Lead sponsor

Source ClinicalTrials.gov

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