Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke

Stroke Clinical Trial

Official title:

Safety and Effectiveness of Transcutaneous Vagus Nerve Stimulation Therapy to Improve Motor Recovery After Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03292159
• Other study ID #: 2017P000129
• Status: Terminated
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Stroke
• Upper Extremity Paresis

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