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New treatment option for Traumatic Brain Injury
Official title NEUROBALANCE Training to Improve Postural Control in Individuals With Traumatic Brain Injury
ClinicalTrials.gov ID: NCT06584591
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.)
See the full eligibility criteria
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.