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NCT Number: NCT03857529

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location status: Recruiting

Location contact

David A Cunningham, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Corticospinal Excitability

    Time frame: up to one hour post intervention

    Change in corticospinal excitability will be measured with transcranial magnetic stimulation

  2. Reaction Time

    Time frame: up to one hour post intervention

    Change in reaction time will be assessed with visual and auditory cues.

Study contacts

Contact information is provided by the study sponsor or research team.

David A Cunningham, PhD

CONTACT

[email protected]

(216) 957-3349

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2019
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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