VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

Not Applicable

Completed

• Conditions: Stroke; Upper Limb Deficits
• Interventions: Device: Vagus Nerve Stimulation (VNS)

• Registration Number: NCT02243020
• Lead Sponsor: MicroTransponder Inc.

Brief Summary

The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Study Start: 2014-10
• Primary Completion: 2016-12
• Results First Submitted: 2018-04-24
• Results First Submitted QC: 2019-04-24
• Results First Posted: 2019-05-15
• Study Completion: 2022-06-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior
2. Age >30 years and <80 years
3. Right or left sided weakness of upper extremity
4. UEFM score within designated range.
5. At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits

Exclusion Criteria

1. History of hemorrhagic stroke
2. Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
3. Significant sensory loss.
4. Presence of ongoing dysphagia or aspiration difficulties.
5. Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.
6. Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study.
7. Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)
8. Severe depression
9. Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
10. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
11. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)
12. Pregnant or plan on becoming pregnant or breastfeeding during the study period
13. Currently require, or likely to require, diathermy during the study duration
14. Any health problem requiring surveillance with MRI imaging
15. Active rehabilitation within 4-weeks prior to therapy
16. Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy
17. Severe spasticity of the upper limb

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vagus Nerve Stimulation (VNS) + Rehabilitation (1)	Vagus Nerve Stimulation (VNS)	This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions.
Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator	Vagus Nerve Stimulation (VNS)	This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.

Primary Outcome Measures

Name	Time	Method
Change in Upper Extremity Fugl-Meyer (UEFM)	6-weeks	Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.

Secondary Outcome Measures

Name	Time	Method
Change in Wolf Motor Function Test Functional Assessment (WMFT)	6-weeks	Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.

Trial Locations

Locations (3)

UT Southwestern; 🇺🇸 Dallas, Texas, United States

UT Houston; 🇺🇸 Houston, Texas, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States