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

Launched by KESSLER FOUNDATION · Sep 2, 2024

Keywords

ClinConnect Summary

The NEUROBALANCE study is looking at a new way to help people who have had a traumatic brain injury (TBI) improve their balance. Researchers want to see if combining robotic balance training with a type of brain stimulation can make a difference for individuals who have struggled with balance issues for more than six months. The study will involve 45 participants, who will be divided into three groups: one group will receive the training with active brain stimulation, another will get training with a placebo (inactive) stimulation, and the third will receive standard rehabilitation care. Over four weeks, participants will attend 12 training sessions, and their balance will be evaluated before, immediately after, and two months after the training.

To be eligible for this study, participants must be between 18 and 75 years old, have been diagnosed with a non-penetrating TBI at least six months prior, and experience balance difficulties. They should be able to stand for at least 20 seconds and walk a short distance, even with support. Those currently in physical therapy or with certain medical conditions may not qualify. Throughout the study, participants will share their experiences regarding the training and brain stimulation, which will help improve future research. This study is particularly important for military members, as TBI and balance challenges are common in this group.

Gender

ALL

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.