Traumatic Brain InjuryVNS for TBINCT07719829
Paired VNS For TBI Rehabilitation
A study testing VNS for TBI group in people with Traumatic Brain Injury and TBI (Traumatic Brain Injury), run by Stony Brook University.
Trial 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 chronic moderate to severe traumatic brain injury (TBI) and subsequent motor deficits. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Traumatic Brain Injury, TBI (Traumatic Brain Injury)
- What is being tested?
- VNS for TBI group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Being tested
- VNS for TBI group
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNS for TBI groupDevice
Group will be implanted with VNS device for chronic TBI
| Study group | Role | What they receive |
|---|---|---|
| VNS Group | Experimental | Group to be implanted with VNS devices Receives: Device: VNS for TBI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 Weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sima Mofakham, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719829
- Sponsor's protocol ID
- Q251552
- Other IDs
- R61MH138612
- Acronym
- VNS for TBI
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired VNS For TBI Rehabilitation
- ClinicalTrials.gov ID
- NCT07719829
- Acronym / sponsor ID
- VNS for TBI / Q251552
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VNS Group | Experimental | Device: VNS for TBI groupGroup to be implanted with VNS devices |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VNS for TBI groupGroup will be implanted with VNS device for chronic TBI | Device | VNS Group |
Primary outcome
Number of Participants With Device- or Procedure-Related Adverse Events
Time frame: 6 Weeks
Adverse events related to VNS device implantation or stimulation will be recorded and graded using CTCAE v5.0.
Change in Upper Limb Range of Motion as Assessed by SeeMe Movement Analysis
Time frame: 6 Weeks
Video-based kinematic analysis of upper limb range of motion, comparing baseline (pre-surgery) to post-training (6 weeks after VNS-paired rehabilitation).
6 secondary outcomes
Change in Disability Rating Scale (DRS) Score
Time frame: 1 Year
Change in Coma Recovery Scale-Revised (CRS-R) Score
Time frame: 6 Weeks
Change in Wolf Motor Function Test (WMFT) Performance Time
Time frame: 6 Weeks
Change in Fugl-Meyer Assessment Upper Extremity (FMA-UE) Score
Time frame: 6 Weeks
Change in Motor Activity Log (MAL) Score
Time frame: 1 Year
Change in EQ-5D-5L Index Score
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing VNS for TBI group in people with Traumatic Brain Injury and TBI (Traumatic Brain Injury), run by Stony Brook University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sima Mofakham, PhD (631-444-1278, sima.mofakham@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device- or Procedure-Related Adverse Events (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.