Transcutaneous Auricular Vagus Nerve Stimulation to Improve Upper Extremity Recovery After Traumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCraig Hospital
About this trial
Upper extremity weakness, impaired coordination, reduced dexterity, and limited arm and hand use may continue after TBI. Repetitive, task-specific rehabilitation may improve function, but recovery can remain incomplete. taVNS is a non-invasive form of electrical stimulation delivered to part of the outer ear. The stimulation is intended to activate nerve pathways involved in learning and brain plasticity while you practice upper extremity tasks. This pilot study will evaluate safety, tolerability, feasibility, and preliminary effects on upper extremity function and cognition. Up to 40 people will take part at Craig Hospital.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
History of TBI requiring inpatient rehabilitation, with resulting upper extremity impairment in at least one limb
Passive range of motion within functional limits at the wrists, shoulders, and elbows.
Able to attend on-site training at Craig Hospital three times per week for four weeks.
Disqualifiers
Recent fracture or contracture that could interfere with the intervention.
Botulinum toxin injections to the upper extremity or hand within the previous three months.
Pregnant, planning pregnancy, or breastfeeding.
Concurrent participation in another drug or device trial that may interfere with this study.
Trial design
Design model
Parallel
Treatments tested in this trial
taVNS + FTP
DeviceBoth groups will receive the same structured upper extremity rehabilitation program. Each 60-minute session will include approximately 40 minutes of upper extremity FTP and 10 minutes of functional carryover activities in a real-world or simulated context, with remaining time used for setup, monitoring, and transition. Training will target gross upper extremity movement, bilateral pinch, bilateral grasp, unilateral grasp, complex or unilateral pinch, and finger isolation. Progression may include increased repetitions or speed, resistance, reduced therapist assistance, and varied task contexts using common objects. Participants assigned to active taVNS will perform upper extremity FTP while receiving stimulation through an earbud electrode positioned on the auricular concha. Current intensity will be individually adjusted to a tolerable level. Stimulation may be reduced, paused, or stopped for discomfort or safety concerns.
FTP + sham taVNS
Other interventionBoth groups will receive the same structured upper extremity rehabilitation program. Each 60-minute session will include approximately 40 minutes of upper extremity FTP and 10 minutes of functional carryover activities in a real-world or simulated context, with remaining time used for setup, monitoring, and transition. Training will target gross upper extremity movement, bilateral pinch, bilateral grasp, unilateral grasp, complex or unilateral pinch, and finger isolation. Progression may include increased repetitions or speed, resistance, reduced therapist assistance, and varied task contexts using common objects. Participants assigned to sham taVNS will complete the identical rehabilitation schedule and activities using identical device placement at the left auricular concha; however, no active stimulation will be delivered. Device setup and study interactions will otherwise be kept as similar as practical between groups.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: taVNS + FTPExperimental treatment 1 intervention
Group B: sham taVNS + FTPSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety of intervention
Number, type, severity, study-relatedness, action taken, and outcome of adverse events.
Time frame
From enrollment to the end of treatment at 4 weeks2
Tolerability of intervention
Stimulation-related discomfort using a 0-10 Numeric Rating Scale during sessions; reasons for pauses or discontinuation.
Time frame
From enrollment to end of treatment at 4 weeks3
Feasibility of intervention
Recruitment, retention, session attendance, proportion completing at least 80% of sessions, dropout attributable to taVNS, and protocol deviations.
Time frame
From enrollment to end of treatment at 4 weeks4
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
A standardized clinical assessment used to evaluate motor impairment and recovery of the arm and hand following neurological injury. The upper extremity portion assesses movement, coordination, reflex activity, and hand function. During the assessment, participants are asked to perform a series of arm, wrist, and hand movements while a trained examiner observes and scores performance. Tasks include movements such as shoulder elevation, elbow flexion and extension, wrist motion, grasping objects, and finger movements. Scores are based on the participant's ability to successfully complete each movement. The assessment is commonly used in rehabilitation research to quantify upper extremity motor impairment and recovery. Administration typically requires approximately 20-30 minutes.
Time frame
Baseline and 4 weeksSecondary outcomes
1
Brief Assessment of Cognition and Treatment (BTACT)
A brief cognitive assessment battery designed to evaluate cognitive functioning across multiple domains. The assessment includes measures of episodic memory, working memory, processing speed, reasoning, executive functioning, verbal fluency, and attention. The BTACT can be administered in a relatively short period of time and provides a broad assessment of global cognitive function. The measure will be administered at baseline and post-treatment to assess cognitive status and explore changes in cognitive performance over the course of study participation. Higher scores generally reflect better cognitive functioning.
Time frame
Baseline and 4 weeks2
Mini-Mental State Examination (MMSE)
A widely used cognitive screening instrument that provides a brief assessment of global cognitive functioning. The MMSE evaluates several cognitive domains, including orientation, attention, concentration, immediate and delayed memory, language, and visuospatial abilities. The assessment consists of a series of structured questions and tasks and yields a total score ranging from 0 to 30, with higher scores indicating better cognitive functioning. The MMSE will be administered at baseline and post-treatment to characterize participants' cognitive status and to assess for changes in overall cognitive functioning following the intervention. The MMSE is commonly used in clinical and research settings as a screening measure for cognitive impairment.
Time frame
Baseline and 4 weeks3
Functional near-infrared spectroscopy (fNIRS)
A non-invasive neuroimaging technique that measures changes in cerebral blood oxygenation associated with cortical brain activity. During study assessments, participants will wear a lightweight fNIRS cap containing near-infrared light sources and detectors positioned over specific regions of the scalp. The fNIRS system continuously records changes in oxygenated hemoglobin (HbO), deoxygenated hemoglobin (HbR), and total hemoglobin (HbT) while participants perform FPT. The primary fNIRS-derived outcomes include changes in oxygenated, deoxygenated, and total hemoglobin concentrations within targeted cortical regions during FTP conditions. These measures provide information regarding cortical activation patterns and neurophysiological responses associated with upper extremity task performance and rehabilitation. fNIRS data collection typically occurs concurrently with task performance and is expected to last approximately 20-30 minutes. The procedure is associated with minimal risk.
Time frame
Baseline and 4 weeks4
Brief Symptom Inventory-18 (BSI-18)
A brief self-report questionnaire used to screen for psychological distress and psychiatric symptoms. The measure consists of 18 items that assess the degree to which participants have been bothered by various symptoms during the past seven days. Items are rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("extremely"). The BSI-18 yields a Global Severity Index (GSI) as an overall measure of psychological distress, as well as three symptom subscales: Somatization, Depression, and Anxiety. Higher scores indicate greater psychological symptom burden. The BSI-18 will be used to characterize participants' emotional and psychological functioning and to monitor symptoms that may influence rehabilitation participation and outcomes.
Time frame
Baseline and 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: