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NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury

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

Who can join

Ages 18 to 75 · All sexes

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.

About the study

Our proposed study, \"NEUROBALANCE,\" aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive brain stimulation in improving balance functions in individuals with chronic traumatic brain injury (TBI). The study will recruit 45 participants who have had a TBI for over six months and experience persistent balance deficits. Participants will be randomized into three groups: (1) robotic balance training with active brain stimulation, (2) robotic balance training with sham brain stimulation, and (3) standard-of-care rehabilitation.

The study will involve 12 training sessions over four weeks, with assessments conducted at baseline, post-training, and two months post-training to evaluate balance recovery and retention. The primary focus is understanding how this intervention affects brain and muscle activity during balance tasks and how these changes translate into functional improvements in clinical outcome measures of balance function. Additionally, participant feedback on brain stimulation and exercise engagement will be collected to inform future studies.

This research is particularly relevant to military service members, as TBI and balance impairments are common among this population. The findings may guide the development of personalized training protocols and contribute to broader rehabilitation strategies.

What is being tested

• Combined (Robotic balance training and high-definition transcranial direct current stimulation) (device)
• Standard of Care Balance Training (other)

Sponsor: Kessler Foundation · Participants: 45 · Started: Aug 1, 2025

Contact the study team

• Vikram Shenoy Handiru, Ph.D. · Phone: 9733243578

Official record on ClinicalTrials.gov — NCT06584591

Locations in the U.S.

Conditions

• Traumatic Brain Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.