Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Amy Friedl, MS, OTR/L
216-957-3598
strokeresearch@metrohealth.org

More Details

Status
Recruiting
Sponsor
MetroHealth Medical Center

Study Contact

Amy Friedl, MS,OTR/L
216-957-3598
strokeresearch@metrohealth.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.