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Recruiting NCT03857529

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

No phase Interventional Stroke Rehabilitation Hand

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcranial direct current stimulation and electrical stimulator.
Who it may be relevant to
Registry conditions: Stroke, Rehabilitation, Hand. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 met

Primary outcome measures

  • Corticospinal Excitability [Time frame: up to one hour post intervention]
  • Reaction Time [Time frame: up to one hour post intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • MetroHealth Medical Center — Cleveland

Identifiers

NCT: NCT03857529 · IRB18-00197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗