Paired VNS For TBI Rehabilitation

NCT07719829 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Q251552
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is evaluating whether pairing vagus nerve stimulation (VNS) with structured upper limb rehabilitation therapy can improve arm and hand function in individuals with moderate to severe traumatic brain injury (TBI). Many people who survive a TBI experience long-term weakness, poor coordination, and difficulty using one arm or hand. These motor impairments can significantly affect independence and quality of life. Traditional rehabilitation can help, but recovery is often incomplete. Vagus nerve stimulation (VNS) is an FDA-approved therapy for certain neurological conditions and involves a small device implanted under the skin in the chest with a lead connected to the vagus nerve in the neck. The device delivers mild electrical pulses to the nerve. In this study, VNS will be paired with goal-directed upper limb rehabilitation exercises. The stimulation is delivered during specific movements in therapy sessions. This "paired stimulation" approach is designed to enhance neuroplasticity - the brain's ability to reorganize and form new connections - which may improve motor recovery. The VNS device used in this study is FDA-approved for other conditions. However, its use paired with rehabilitation for upper limb recovery after traumatic brain injury is investigational. Participants in this study will: Undergo surgical implantation of the VNS device. Participate in structured upper limb rehabilitation therapy sessions where stimulation is paired with specific movements. Complete follow-up visits and assessments to measure changes in arm and hand function, strength, dexterity, and overall recovery. The main goal of the study is to determine whether paired VNS and rehabilitation improves upper limb motor function compared to rehabilitation alone. Safety will also be closely monitored, including surgical outcomes and any device-related effects. This study may help determine whether VNS paired with rehabilitation is a safe and effective way to enhance motor recovery after traumatic brain injury. Findings from this research could contribute to improved treatment strategies for individuals living with long-term motor impairments following TBI. Participation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.

Conditions

Traumatic Brain Injury; TBI (Traumatic Brain Injury)

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Device- or Procedure-Related Adverse Events

  Adverse events related to VNS device implantation or stimulation will be recorded and graded using CTCAE v5.0.

  6 Weeks

• Change in Upper Limb Range of Motion as Assessed by SeeMe Movement Analysis

  Video-based kinematic analysis of upper limb range of motion, comparing baseline (pre-surgery) to post-training (6 weeks after VNS-paired rehabilitation).

  6 Weeks

Secondary Outcomes (6)

• Change in Disability Rating Scale (DRS) Score

  1 Year

• Change in Coma Recovery Scale-Revised (CRS-R) Score

  6 Weeks

• Change in Wolf Motor Function Test (WMFT) Performance Time

  6 Weeks

• Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score

  6 Weeks

• Change in Motor Activity Log (MAL) Score

  1 Year

Study Arms (1)

VNS Group

EXPERIMENTAL

Group to be implanted with VNS devices

Device: VNS for TBI group

Interventions

VNS for TBI group DEVICE

Group will be implanted with VNS device for chronic TBI

VNS Group

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22-80 years
• History of severe TBI (initial GCS ≤ 8)
• Regained consciousness with capacity to consent to the study
• At least six months since injury
• Full recovery of consciousness with command following (mGCS = 6)
• Ongoing motor impairment with dependence in activities of daily living (modified Rankin Scale, mRS = 3-4)
• Clinically stable for VNS implantation

You may not qualify if:

• No capacity to consent to the study
• History of stroke
• History of cognitive disorder or other neurodegenerative disorder
• History of epilepsy treated by VNS
• History of brain tumors (primary or metastatic)
• Requires diathermy
• Pregnant
• Previously implanted vagus nerve stimulator
• Extensive prior neck surgery preventing dissection of the vagus nerve
• History of severe spasticity, vagus nerve damage, or hearing loss

Sponsors & Collaborators

• Stony Brook University: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Sima Mofakham, PhD

CONTACT

631-444-1278; sima.mofakham@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 22, 2026

Record last verified: 2026-06