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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
MetroHealth Medical Center
Study ID
NCT03857529
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 1, 2019
Status verified
Sep 2025
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: conventional tDCS concurrent with CCFES
    tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
  • Experimental: unconventional tDCS concurrent with CCFES
    tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
  • Experimental: conventional tDCS preceding CCFES
    tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
  • Experimental: unconventional tDCS preceding CCFES
    tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
  • Sham Comparator: sham tDCS with CCFES
    sham tDCS preceding and concurrent with CCFES

Primary Outcome Measure

Corticospinal Excitability [ Time Frame: up to one hour post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MetroHealth Medical CenterClevelandOhio44109
David A Cunningham, PhD

Find similar trials in Cleveland, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
MetroHealth Medical Center· Cleveland, OH

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