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Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active RAVANS concurrent with arm motor training
Inactive RAVANS concurrent with arm motor training
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, vagus nerve stimulation, upper extremity paresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior;
  • Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4);
  • Age ≥ 18;
  • Able to provide written informed consent.

Exclusion Criteria:

  • Implanted electronic device (e.g., pacemaker, neurostimulator);
  • Pregnancy;
  • Major psychiatric or medical condition that could interfere with study participation;
  • Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia);
  • Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by Stroke Impact Scale item 7 (SIS-hand) mean score < 4 (scale: 0-5);
  • History of seizure during year before stroke or > 1 post-stroke seizure;
  • Significant cognitive or language impairment that would interfere with informed consent or study participation;
  • Severe dysphagia;
  • Bradycardia defined as resting heart rate < 50 bpm;
  • Nonsustained ventricular tachycardia;
  • Cardiac conduction disorder (i.e., bundle branch block, heart block, long Q-T syndrome);
  • History of asystole;
  • History of recurrent vaso-vagal syncope;
  • Hypotension defined as blood pressure < 90/60 mmHg.

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

RAVANS

Sham stimulation

Arm Description

Outcomes

Primary Outcome Measures

Upper extremity motor impairment
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score

Secondary Outcome Measures

Upper extremity motor function
Change in Action Research Arm Test (ARAT) score
Grip force control
Change in accuracy, variability and temporal structure of performance on a grip force control task
Upper extremity disability
Change in hand subtest of Stroke Impact Scale (SIS-hand) score
Mood state, anxiety and depression
Change in Hospital Anxiety and Depression Scale (HADS) scores

Full Information

First Posted
September 20, 2017
Last Updated
September 14, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Dana Foundation, Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03292159
Brief Title
Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke
Official Title
Safety and Effectiveness of Transcutaneous Vagus Nerve Stimulation Therapy to Improve Motor Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
funding not continued
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana Foundation, Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.
Detailed Description
This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis
Keywords
stroke, vagus nerve stimulation, upper extremity paresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAVANS
Arm Type
Experimental
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Active RAVANS concurrent with arm motor training
Intervention Description
Patient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training
Intervention Type
Device
Intervention Name(s)
Inactive RAVANS concurrent with arm motor training
Intervention Description
Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
Primary Outcome Measure Information:
Title
Upper extremity motor impairment
Description
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score
Time Frame
Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Secondary Outcome Measure Information:
Title
Upper extremity motor function
Description
Change in Action Research Arm Test (ARAT) score
Time Frame
Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Title
Grip force control
Description
Change in accuracy, variability and temporal structure of performance on a grip force control task
Time Frame
Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Title
Upper extremity disability
Description
Change in hand subtest of Stroke Impact Scale (SIS-hand) score
Time Frame
Baseline to 3 months post-stroke
Title
Mood state, anxiety and depression
Description
Change in Hospital Anxiety and Depression Scale (HADS) scores
Time Frame
Baseline to 3 months post-stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior; Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4); Age ≥ 18; Able to provide written informed consent. Exclusion Criteria: Implanted electronic device (e.g., pacemaker, neurostimulator); Pregnancy; Major psychiatric or medical condition that could interfere with study participation; Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia); Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by Stroke Impact Scale item 7 (SIS-hand) mean score < 4 (scale: 0-5); History of seizure during year before stroke or > 1 post-stroke seizure; Significant cognitive or language impairment that would interfere with informed consent or study participation; Severe dysphagia; Bradycardia defined as resting heart rate < 50 bpm; Nonsustained ventricular tachycardia; Cardiac conduction disorder (i.e., bundle branch block, heart block, long Q-T syndrome); History of asystole; History of recurrent vaso-vagal syncope; Hypotension defined as blood pressure < 90/60 mmHg.
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

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Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

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