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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03292159
Other study ID # 2017P000129
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date May 17, 2018
Est. completion date November 20, 2018

Study information

Verified date September 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date November 20, 2018
Est. primary completion date November 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active RAVANS concurrent with arm motor training
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
Inactive RAVANS concurrent with arm motor training
Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training

Locations

Country Name City State
United States Spaulding Rehabilitation Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Dana Foundation, Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Upper extremity motor function Change in Action Research Arm Test (ARAT) score Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Secondary Grip force control Change in accuracy, variability and temporal structure of performance on a grip force control task Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Secondary Upper extremity disability Change in hand subtest of Stroke Impact Scale (SIS-hand) score Baseline to 3 months post-stroke
Secondary Mood state, anxiety and depression Change in Hospital Anxiety and Depression Scale (HADS) scores Baseline to 3 months post-stroke
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