NCT04129242

Brief Summary

This study explores the use of a new form of neuromodulation known as transcutaneous auricular vagus nerve stimulation (taVNS) which stimulates the ear. This stimulation will be delivered concurrently with upper limb motor rehabilitation training (3 days/week for 4 weeks) in chronic stroke patients. Patients will undergo a series of baseline assessments (including a brain scan), a 4-week course of motor rehabilitation, and post-assessments (including a second brain scan)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1 stroke

Timeline
Completed

Started Feb 2020

Typical duration for early_phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

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 23, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 19, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

September 23, 2019

Results QC Date

November 30, 2023

Last Update Submit

February 5, 2024

Conditions

Stroke

Keywords

StrokeRehabilitationVagus Nerve StimulationBrain StimulationOccupational Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Fugl-Meyer Assessment of the Upper Extremity

    The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Possible aggregate scores range from 0/66 to 66/66 points. Higher scores indicate greater levels of arm movement ability.

    Mean change in FMA-UE score after 4 weeks of rehab, compared to baseline

Study Arms (2)

"paired" taVNS + Task Specific Training

ACTIVE COMPARATOR
Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training

"unpaired" taVNS + Task Specific Training

ACTIVE COMPARATOR
Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc TrainingDEVICE

A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.

"paired" taVNS + Task Specific Training"unpaired" taVNS + Task Specific Training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Ischemic or hemorrhagic stroke that occurred at least 6 months prior
  • Completed conventional rehabilitation therapy at least one month prior
  • Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than or equal to 58 (out of 66)

You may not qualify if:

  • Primary intracerebral hematoma, or subarachnoid hemorrhage
  • Bilateral upper extremity weakness
  • Other concomitant neurological disorders affecting upper extremity motor function
  • Documented history of dementia before or after stroke
  • Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment
  • Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) \>=180/100mmHg at baseline
  • Contraindicated for MRI scanning.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Bashar Badran
Organization
The Medical University of SC
badran@musc.edu
843-792-6076

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 23, 2019

First Posted

October 16, 2019

Study Start

February 19, 2020

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

February 28, 2024

Results First Posted

February 28, 2024

Record last verified: 2024-02

Locations

US(1)