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

Purpose

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.

Conditions

  • Stroke
  • Rehabilitation
  • Hand

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
conventional tDCS concurrent with CCFES 		tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
  • Device: transcranial direct current stimulation and electrical stimulator
    Contralaterally Controlled Functional Electrical Stimulation: 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 will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.
Experimental
unconventional tDCS concurrent with CCFES 		tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
  • Device: transcranial direct current stimulation and electrical stimulator
    Contralaterally Controlled Functional Electrical Stimulation: 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 will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.
Experimental
conventional tDCS preceding CCFES 		tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
  • Device: transcranial direct current stimulation and electrical stimulator
    Contralaterally Controlled Functional Electrical Stimulation: 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 will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.
Experimental
unconventional tDCS preceding CCFES 		tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
  • Device: transcranial direct current stimulation and electrical stimulator
    Contralaterally Controlled Functional Electrical Stimulation: 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 will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.
Sham Comparator
sham tDCS with CCFES 		sham tDCS preceding and concurrent with CCFES
  • Device: transcranial direct current stimulation and electrical stimulator
    Contralaterally Controlled Functional Electrical Stimulation: 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 will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES). Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.

Recruiting Locations

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
David A Cunningham, PhD

More Details

Status
Recruiting
Sponsor
MetroHealth Medical Center

Study Contact

David A Cunningham, PhD
(216) 957-3349
Dxc536@case.edu