NCT03292159

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

September 20, 2017

Last Update Submit

September 14, 2021

Conditions

StrokeUpper Extremity Paresis

Keywords

strokevagus nerve stimulationupper extremity paresis

Outcome Measures

Primary Outcomes (1)

  • Upper extremity motor impairment

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

    Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke

Secondary Outcomes (4)

  • Upper extremity motor function

    Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke

  • Grip force control

    Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke

  • Upper extremity disability

    Baseline to 3 months post-stroke

  • Mood state, anxiety and depression

    Baseline to 3 months post-stroke

Study Arms (2)

RAVANS

EXPERIMENTAL
Device: Active RAVANS concurrent with arm motor training

Sham stimulation

SHAM COMPARATOR
Device: Inactive RAVANS concurrent with arm motor training

Interventions

Active RAVANS concurrent with arm motor trainingDEVICE

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

RAVANS
Inactive RAVANS concurrent with arm motor trainingDEVICE

Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training

Sham stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Radiology, Harvard Medical School

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

May 17, 2018

Primary Completion

November 20, 2018

Study Completion

November 20, 2018

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

US(1)