Overview

This trial is active, not recruiting.

Conditions stroke, upper limb deficits
Treatment vagus nerve stimulation (vns)
Sponsor MicroTransponder Inc.
Start date October 2014
End date December 2016
Trial size 17 participants
Trial identifier NCT02243020, MT-St-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This group receives vagus nerve stimulation during rehabilitation.
vagus nerve stimulation (vns) VNS
(Active Comparator)
This group receives rehabilitation and VNS, but the VNS is different than given in the other group. It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
vagus nerve stimulation (vns) VNS

Primary Outcomes

Measure
Upper Limb Fugl-Meyer (UEFM)
time frame: 6-weeks
Wolf Motor Function Test (WMFT)
time frame: 6-weeks

Secondary Outcomes

Measure
Box and Block Test
time frame: 6-weeks
9-hole Peg
time frame: 6-weeks

Eligibility Criteria

Male or female participants from 30 years up to 80 years old.

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

Additional Information

Official title Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)
Principal investigator Patty Smith, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by MicroTransponder Inc..