Paired VNS For TBI Rehabilitation (VNS for TBI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TBI (Traumatic Brain Injury); Traumatic Brain Injury
• Intervention / Treatment: Device: VNS for TBI group

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sima Mofakham, PhD; Phone Number: 631-444-1278; Email: sima.mofakham@stonybrookmedicine.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VNS Group; Group to be implanted with VNS devices	Device: VNS for TBI group; Group will be implanted with VNS device for chronic TBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disability Rating Scale (DRS) Score	RS score (range 0 [no disability] to 29 [extreme vegetative state]; lower scores indicate better outcome). Magnitude of change will be used to estimate effect size for power calculation in a future multicenter randomized trial.	1 Year
Change in Coma Recovery Scale-Revised (CRS-R) Score	CRS-R total score (range 0-23; higher scores indicate better neurobehavioral function), comparing baseline to post-training.	6 Weeks
Change in Wolf Motor Function Test (WMFT) Performance Time	Time (seconds) to complete standardized WMFT tasks; lower time indicates better function. Comparing baseline to post-training.	6 Weeks
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score	FMA-UE score (range 0-66; higher scores indicate better motor function), comparing baseline to post-training.	6 Weeks
Change in Motor Activity Log (MAL) Score	MAL Amount of Use and Quality of Movement subscales (range 0-5 each; higher scores indicate better real-world arm use).	1 Year
Change in EQ-5D-5L Index Score	EQ-5D-5L index score (range 0 [death] to 1 [full health]; higher scores indicate better quality of life).	1 Year

Collaborators and Investigators

• Sponsor: Stony Brook University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: Q251552

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes