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

Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation; Hand
• Intervention / Treatment: Device: transcranial direct current stimulation and electrical stimulator

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David A Cunningham, PhD; Phone Number: (216) 957-3349; Email: Dxc536@case.edu

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • MetroHealth Medical Center
      • Contact: David A Cunningham, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corticospinal Excitability	Change in corticospinal excitability will be measured with transcranial magnetic stimulation	up to one hour post intervention
Reaction Time	Change in reaction time will be assessed with visual and auditory cues.	up to one hour post intervention

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center
• Investigators: Principal Investigator: David A Cunningham, PhD, MetroHealth Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: IRB18-00197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and results will be made available by request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No