NEUROBALANCE training to improve balance after traumatic brain injury

Neuromodulation-Enhanced Use of RObotic Balance Training to Improve Postural Control in Individuals With Traumatic Brain Injury

This study will test whether combining robotic balance training with noninvasive brain stimulation helps adults with chronic traumatic brain injury who still have balance problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Kessler Foundation (Academic / other)
• Locations: 1 site (West Orange, New Jersey)
• Trial ID: NCT06584591 on ClinicalTrials.gov

What this trial studies

This randomized study will enroll 45 adults with non‑penetrating traumatic brain injury at least six months after injury and persistent balance deficits. Participants will be randomized to robotic balance training plus active HD‑tDCS, robotic balance training plus sham stimulation, or standard-of-care balance rehabilitation. The intervention consists of 12 training sessions over four weeks using the Hunova robotic platform, with assessments at baseline, immediately post-training, and two months later to measure balance outcomes, brain and muscle activity, and retention. Study outcomes include clinical balance measures, laboratory measures of postural control, and neurophysiologic markers.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with a non‑penetrating TBI at least six months earlier who have persistent balance complaints (e.g., Berg Balance Scale ≤50), can stand for ≥20 seconds and walk ≥10 meters, and can follow study instructions.

Not a fit: People with penetrating TBI or recent stroke, current participation in regular balance physical therapy, significant peripheral neuromuscular or orthopedic lower‑limb problems, persistent pain limiting participation, or inability to consent/comply are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could produce longer-lasting improvements in balance and reduce fall risk, improving daily function for people with chronic TBI.

How similar studies have performed: Previous studies of robotic balance devices and of tDCS separately have shown promising but mixed short‑term improvements, while combining HD‑tDCS with the Hunova platform represents a relatively novel, less-tested approach.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18-75 years
2. Diagnosed with a non-penetrating TBI at least six months before the screening.
3. Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
4. Ability to stand upright with or without support for at least 20 seconds
5. Ability to walk with or without a walking aid for at least ten meters
6. Not planning to change medication in the next four months
7. Minimum Cognitive Ability to understand the verbal instructions and comply with the study procedures, as determined by the University of California, San Diego, Brief Assessment of Capacity to Consent Instrument (UBACC).

Exclusion Criteria:

1. Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
2. Having a stroke or a penetrating TBI.
3. Affected by the peripheral nerve injury, neuromuscular conditions, or orthopedic issues of lower limbs before TBI, or have any persistent pain or difficulty maintaining blood pressure while upright.
4. Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.
5. Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.
6. Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)
7. Not being pregnant or thinking of becoming pregnant during the study period.
8. Diagnosed with alcohol or substance abuse in the last three years.
9. Contraindications to TMS, including the presence of metallic implants in the head and history of seizures or medication-resistant epilepsy.

Where this trial is running

West Orange, New Jersey

• Kessler Foundation — West Orange, New Jersey, United States (Recruiting)

Study contacts

• Principal investigator: Vikram Shenoy Handiru, Ph.D. — Kessler Foundation
• Study coordinator: Vikram Shenoy Handiru, Ph.D.

Conditions Traumatic Brain Injury; TBI; Diffuse Axonal Brain Injury; Brain Injuries, Traumatic