~30 spots leftby Mar 2027

Robotic Balance Training + Brain Stimulation for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)
Overseen byVikram Shenoy Handiru, Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Kessler Foundation
No Placebo Group

Trial Summary

What is the purpose of this trial?

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

This trial is for individuals aged 18-75 who have had a non-penetrating traumatic brain injury (TBI) at least six months ago and are experiencing balance issues. They must be able to stand with or without support, walk at least ten meters, not change medications soon, and understand instructions.

Inclusion Criteria

I am between 18 and 75 years old.
I can walk at least 10 meters with or without help.
Not planning to change medication in the next four months
See 4 more

Exclusion Criteria

I am currently in a physical therapy program or study for balance.
Severe visual impairment (e.g., spatial neglect) or hearing problems that may affect study compliance
I have had a stroke or a serious brain injury.
See 6 more

Treatment Details

Interventions

  • NEUROBALANCE Training (Behavioural Intervention)
Trial OverviewThe NEUROBALANCE study tests if robotic balance training combined with brain stimulation can improve balance in people with chronic TBI. Participants will be divided into three groups: one receiving active brain stimulation, another sham stimulation, and the last standard care.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SOC Control GroupExperimental Treatment1 Intervention
The SOC control group participants will perform conventional physical therapy exercises delivered by a trained PT.
Group II: RBT + Active HD-tDCS GroupExperimental Treatment1 Intervention
Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON for 20 minutes.
Group III: RBT + Sham HD-tDCS GroupPlacebo Group1 Intervention
Participants will engage in balance and postural control training on a robotic balance platform called Hunova (Movendo, Italy). Before balance training, the current intensity of 2 mA will be delivered to the leg motor area identified using neuronavigated transcranial magnetic stimulation, and the stimulation will be turned ON transiently for 30 s, to provide a sensation of stimulation.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Kessler FoundationWest Orange, NJ
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Who Is Running the Clinical Trial?

Kessler FoundationLead Sponsor
United States Department of DefenseCollaborator

References