VNS-supplemented Motor Retraining After Stroke

Not Applicable

Completed

• Conditions: Stroke, Acute
• Interventions: Other: Training; Other: Sham Stimulation; Other: Vagus Nerve Stimulation

• Registration Number: NCT04088578
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-13
• Study Start: 2019-09-22
• Primary Completion: 2021-11-09
• Study Completion: 2021-11-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Sham Stimulation	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.
Vagus nerve stimulation (VNS)	Vagus Nerve Stimulation	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.
Vagus nerve stimulation (VNS)	Training	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.
Sham stimulation	Training	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.

Primary Outcome Measures

Name	Time	Method
Change in time-on-target score.	3 weeks	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States