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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857529
• Other study ID #: IRB18-00197
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: November 2023
• Source: MetroHealth Medical Center
• Contact: David A Cunningham, PhD
• Phone: (216) 957-3349
• Email: Dxc536[@]case.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand
• Rehabilitation
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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