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

NCT03857529 | Recruiting

• 1 other identifier: IRB18-00197
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Rehabilitation; Hand

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (5)

conventional tDCS concurrent with CCFES

EXPERIMENTAL

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Device: transcranial direct current stimulation and electrical stimulator

unconventional tDCS concurrent with CCFES

EXPERIMENTAL

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Device: transcranial direct current stimulation and electrical stimulator

conventional tDCS preceding CCFES

EXPERIMENTAL

tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere

Device: transcranial direct current stimulation and electrical stimulator

unconventional tDCS preceding CCFES

EXPERIMENTAL

tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere

Device: transcranial direct current stimulation and electrical stimulator

sham tDCS with CCFES

SHAM COMPARATOR

sham tDCS preceding and concurrent with CCFES

Device: transcranial direct current stimulation and electrical stimulator

Interventions

transcranial direct current stimulation and electrical stimulator DEVICE

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.

conventional tDCS concurrent with CCFES; conventional tDCS preceding CCFES; sham tDCS with CCFES; unconventional tDCS concurrent with CCFES; unconventional tDCS preceding CCFES

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 21
• ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
• Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
• Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
• Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
• Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
• Medically stable
• ≥ 10° finger extension
• 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
• Skin intact on hemiparetic arm, hand and scalp
• While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
• No significant visual or hearing impairment

You may not qualify if:

• 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).
• Uncontrolled seizure disorder
• Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
• Cardiac pacemaker or other implanted electronic device and/or stent
• Pregnant
• Intramuscular botox injections in any upper extremity muscle in the last 3 months
• Insensate arm, forearm, or hand
• Severely impaired cognition and communication
• Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
• Severe shoulder or hand pain (unable to position hand in the workspace without pain)
• Metal implant in the head

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• David A Cunningham, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Cunningham, PhD

CONTACT

(216) 957-3349; Dxc536@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Physical Medicine and Rehabilitation, School of Medicine

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: August 1, 2019
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)