VNS-supplemented Motor Retraining After Stroke

University of Pittsburgh

Status: Completed

Conditions: Stroke, Acute

Treatments: Other: Vagus Nerve Stimulation; Other: Training; Other: Sham Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04088578

STUDY19040394 (Aim 2)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Vagus nerve stimulation (VNS)

Experimental group

Description:

Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. VNS will be delivered when a minimum level of accuracy has been achieved.

Treatment:

Other: Training

Other: Vagus Nerve Stimulation

Sham stimulation

Sham Comparator group

Description:

Stroke and control subjects will undergo 3 testing sessions and 8 training sessions in these experiments. Subjects will hold a force transducer between the index finger and thumb to control the path of an object through targets displayed on a computer monitor. Sham stimulation will be delivered when a minimum level of accuracy has been achieved.

Treatment:

Other: Sham Stimulation

Other: Training