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Purpose

Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have severe upper extremity motor deficit after a single stroke - Stroke onset at least 12 months ago

Exclusion Criteria

  • Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment - Untreated depression - History of multiple strokes - History of seizure - History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness - Positive pregnancy test or being of childbearing age and not using appropriate contraception - Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain - Cardiac or neural pacemakers or implanted medication pumps - Receptive aphasia

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active PNS during training 		Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm.
  • Device: Peripheral nerve stimulation (PNS)
    Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
  • Behavioral: Intensive upper extremity motor training
Active Comparator
Active PNS before training 		Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm.
  • Device: Peripheral nerve stimulation (PNS)
    Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
  • Behavioral: Intensive upper extremity motor training
Sham Comparator
Sham PNS during training 		Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm.
  • Device: Peripheral nerve stimulation (PNS)
    Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
  • Behavioral: Intensive upper extremity motor training

Recruiting Locations

More Details

NCT ID
NCT04576013
Status
Terminated
Sponsor
University of Kentucky

Detailed Description

This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.