VNS-supplemented Motor Retraining After Stroke

University of Pittsburgh26 enrolled

Overview

The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.

To establish a link between the physiological mechanisms driving enhanced motor control in response to VNS, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. In separate groups, VNS or sham stimulation will be paired with movement when a minimal time-on-target (ToT) is achieved.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke, Acute

Interventions

TrainingOTHER

Controlling movement of an object on computer screen by adjusting muscle activity.

Vagus Nerve StimulationOTHER

Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.

Sham StimulationOTHER

Sub-threshold stimulation that does not activate neural structures.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: INDIVIDUALS WHO HAVE HAD A STROKE: 1. Diagnosis of first ever stroke 2. At least 6 months after stroke onset 3. Motor-evoked potentials in hand/arm muscles 4. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. ALL INDIVIDUALS: 5. Between the ages of 18 and 75 years old Exclusion Criteria: INDIVIDUALS WHO HAVE HAD A STROKE: 1. Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators ALL INDIVIDUALS: 2. Neurological disorder(s) influencing movement (besides stroke) 3. History of seizure or epilepsy 4. Metallic brain implants 5. Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers 6. Pregnant or expecting to become pregnant 7. Difficulty maintaining alertness and/or remaining still 8. Silicone or plastic allergy 9. History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Change in time-on-target score.

The score reflects the total time the object overlaps any part of targets, expressed as a percentage (0-100) of the total possible time. Thus, a score of 0 is the worst possible score, whereas, 100 is the best possible score. The primary endpoint is the change from baseline (ie, before training) in the time-on-target score.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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