Status:
RECRUITING
NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Brain Injury
TBI
Eligibility:
All Genders
18-75 years
Phase:
NA
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 fu...
Detailed Description
Background: Traumatic Brain Injury (TBI) is one of the severe health conditions with debilitating consequences, affecting more than 2.5 million individuals in the US alone. Balance dysfunction is one ...
Eligibility Criteria
Inclusion
- Aged between 18-75 years
- Diagnosed with a non-penetrating TBI at least six months before the screening.
- Have complaints of impaired balance and poor postural control determined by a BBS score of ≤50.
- Ability to stand upright with or without support for at least 20 seconds
- Ability to walk with or without a walking aid for at least ten meters
- Not planning to change medication in the next four months
- 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
- Currently undergoing any regular physical therapy program or research studies focusing on balance functions.
- Having a stroke or a penetrating TBI.
- 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.
- Have a scalp or skin condition (e.g., psoriasis or eczema) on the scalp near the stimulation site.
- Severe visual impairment (e.g., spatial neglect) or hearing problems may affect study compliance.
- Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)
- Not being pregnant or thinking of becoming pregnant during the study period.
- Diagnosed with alcohol or substance abuse in the last three years.
- Contraindications to TMS, including the presence of metallic implants in the head and history of seizures or medication-resistant epilepsy.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06584591
Start Date
August 1 2025
End Date
December 1 2027
Last Update
August 6 2025
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052