Robotic Balance Training + Brain Stimulation for Traumatic Brain Injury

Overseen By Kathleen Goworek, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Stroke, Neuromuscular, Orthopedic, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with long-term balance issues following a traumatic brain injury (TBI). It combines NEUROBALANCE Training, a robotic balance training, with a type of brain stimulation to determine if this approach improves balance more effectively than standard physical therapy. Participants will be divided into three groups: one group will receive both the robotic training and real brain stimulation, another will undergo robotic training with sham stimulation, and the last group will participate in regular therapy. Ideal candidates are those who experienced a TBI over six months ago and continue to have difficulty standing or walking steadily. The trial aims to discover better ways to help individuals regain balance and enhance their daily lives. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could significantly improve quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not plan to change their medication in the next four months.

What prior data suggests that this combined intervention is safe for individuals with chronic traumatic brain injury?

Research shows that the type of noninvasive brain stimulation used in this study is generally easy for participants to handle. Studies have found that people usually experience only mild side effects, such as itching or tingling where the stimulation is applied. These effects are temporary and often disappear shortly after the session ends.

Robotic balance training, another part of the treatment, has been successfully used in many rehabilitation programs. It is designed to be safe and is usually well-received by users. No major negative events have been reported, making it a dependable way to improve balance in people with long-term brain injuries.

In summary, existing research considers both parts of the treatment safe. Participants can feel reassured about the low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Robotic Balance Training combined with Brain Stimulation treatment for traumatic brain injury because it introduces a new, tech-driven approach to rehabilitation. Unlike standard physical therapy, this method uses a robotic balance platform, Hunova, to improve balance and postural control. The addition of high-definition transcranial direct current stimulation (HD-tDCS) targets the leg motor area in the brain, potentially enhancing neuroplasticity and recovery. This dual approach could offer a more effective and faster recovery process compared to traditional exercises alone.

What evidence suggests that this trial's treatments could be effective for improving balance in individuals with traumatic brain injury?

This trial will compare different approaches to balance training for individuals with traumatic brain injury (TBI). Participants in one arm will receive robotic balance training combined with active brain stimulation, while another group will receive robotic balance training with sham brain stimulation. Studies have shown that robotic balance training with gentle brain stimulation can aid those with long-term balance problems after a TBI. Research suggests this combination helps the brain use areas involved in movement and balance more effectively. This training might improve coordination between the brain and muscles, enhancing stability. Early findings indicate that this approach can improve both the body's reaction to losing balance and its preparation to maintain balance. Overall, this treatment offers promising support for those with balance issues after a TBI. ^{1 2 3 5 6}

Who Is on the Research Team?

Vikram Shenoy Handiru, Ph.D.

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

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

Not planning to change medication in the next four months

I can walk at least 10 meters with or without help.

I can stand up straight for at least 20 seconds, with or without support.

Exclusion Criteria

Severe visual impairment (e.g., spatial neglect) or hearing problems that may affect study compliance

I am currently in a physical therapy program or study for balance.

I have had a stroke or a serious brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 sessions of robotic balance training with either active or sham brain stimulation over four weeks

4 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments conducted at baseline, post-training, and two months post-training

2 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NEUROBALANCE Training

Trial Overview The 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.

How Is the Trial Designed?

Group I: SOC Control Group Experimental Treatment 1 Intervention

The SOC control group participants will perform conventional physical therapy exercises delivered by a trained PT.

Group II: RBT + Active HD-tDCS Group Experimental Treatment 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

A study involving 31 individuals with chronic traumatic brain injury (TBI) found that treadmill training combined with virtual reality is safe and feasible, with no serious adverse events reported during the 4-week intervention.

All participants showed improvements in balance and mobility measures after the training, indicating that both virtual reality and treadmill training could be effective methods for enhancing recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of virtual reality and treadmill training in traumatic brain injury: a randomized controlled pilot trial. Tefertiller, C., Ketchum, JM., Bartelt, P., et al.[2022]

Individuals with moderate to severe traumatic brain injury (TBI) show significant impairments in balance control, particularly in anticipatory and reactive mechanisms, as indicated by increased spectral power in balance tasks.

Recovery in balance control occurs over time, with improvements in inter-limb coherence and high-frequency balance measures, suggesting that targeted rehabilitation addressing weight-bearing asymmetries could enhance balance and reduce fall risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectral analysis of centre of pressure identifies altered balance control in individuals with moderate-severe traumatic brain injury. Habib Perez, O., Green, RE., Mochizuki, G.[2021]

A Perturbation-based Balance Training program with visual cues (PBTvc) was evaluated in a feasibility study involving two participants with chronic Traumatic Brain Injury (TBI), showing promising improvements in balance mechanisms.

After 16 sessions of PBTvc, participants demonstrated enhanced trunk stability and reduced time to regain balance during perturbations, along with better scores on balance assessments, indicating potential for functional recovery in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Anticipatory and Compensatory Postural Responses to Improve Balance in Individuals with TBI. Tendolkar, PA., Ibironke, O., Nolan, KJ., et al.[2023]

In a study of 31 participants with chronic mild traumatic brain injury (mTBI), vestibular rehabilitation therapy significantly improved balance, with both groups showing medium effect-sized decreases in symptoms and large increases in balance scores after 6 weeks of treatment.

The group receiving auditory biofeedback (ABF) showed trends towards better outcomes in motor activation and reduced time delay compared to the group without ABF, suggesting that incorporating ABF may enhance rehabilitation effectiveness for balance control in mTBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of augmenting traditional rehabilitation with audio biofeedback in people with persistent imbalance following mild traumatic brain injury. Campbell, KR., Peterka, RJ., Fino, PC., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06584591

NEUROBALANCE Training to Improve Postural Control in ... Our proposed study, "NEUROBALANCE," aims to evaluate the effectiveness of a combined intervention involving robotic balance training and noninvasive ...

2. kesslerfoundation.org kesslerfoundation.org/press-release/kessler-foundation-researchers-advance-traumatic-brain-injury-rehabilitation

Kiran Karunakaran, PhD, and Vikram Shenoy Handiru ... This intervention will result in improved and efficient recruitment of cognitive and sensorimotor brain regions during gait and balance and will ...

3. trialx.com trialx.com/clinical-trials/listings/300947/neurobalance-training-to-improve-postural-control-in-individuals-with-traumatic-brain-injury/

NEUROBALANCE Training to Improve Postural Control in ... Overall, we anticipate that the combined intervention will improve reactive and anticipatory postural control, position sense, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8594144/

Results From a Randomized Controlled Trial to Address ... Studies have shown that individuals with neurologic conditions who utilize VR have improved aspects of balance1,12-20,23-28,32,33 and some have also reported ...

5. withpower.com withpower.com/trial/phase-brain-injuries-9-2024-466a8

Robotic Balance Training + Brain Stimulation for Traumatic ... Trial Overview The NEUROBALANCE study tests if robotic balance training combined with brain stimulation can improve balance in people with chronic TBI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9775990/

Innovative Technologies in the Neurorehabilitation of ... This systematic review has demonstrated the beneficial role of innovative technologies when applied to cognitive rehabilitation in patients with TBI.