NEUROBALANCE training to improve balance after traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: vshenoy@kesslerfoundation.org
• Phone: 9733243578

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.