NCT06584591 NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
| NCT ID | NCT06584591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-08-01 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Vikram Shenoy Handiru, Ph.D.
PRINCIPAL INVESTIGATOR
Kessler Foundation
Frequently Asked Questions
Who can join the NCT06584591 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06584591 currently recruiting?
Yes, NCT06584591 is actively recruiting participants. Contact the research team at vshenoy@kesslerfoundation.org for enrollment information.
Where is the NCT06584591 trial being conducted?
This trial is being conducted at West Orange, United States.
Who is sponsoring the NCT06584591 clinical trial?
NCT06584591 is sponsored by Kessler Foundation. The principal investigator is Vikram Shenoy Handiru, Ph.D. at Kessler Foundation. The trial plans to enroll 45 participants.