An interventional study of VNS for TBI group in Traumatic Brain Injury and TBI (Traumatic Brain Injury), sponsored by Stony Brook University. Not yet recruiting. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Stony Brook University · Not applicable, Interventional, and Treatment
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 chronic moderate to severe traumatic brain injury (TBI) and subsequent motor deficits.
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. If the results are promising, future studies plan to also include patients with acute TBI.
Participation is voluntary. All participants will be carefully evaluated to determine eligibility, and informed consent will be obtained before enrollment.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Stony Brook University is the lead sponsor of 197 studies on the registry; 36 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group to be implanted with VNS devices
Device: VNS for TBI group
Group will be implanted with VNS device for chronic TBI
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.
Time frame: 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).
Time frame: 6 Weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 1 Year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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