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

Trial Summary

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 data supports the effectiveness of the treatment NEUROBALANCE Training for traumatic brain injury?

Research shows that combining physical therapy with brain stimulation can help improve balance and movement in people with traumatic brain injury. For example, a study found that using a balance training program with visual cues improved balance and stability in participants with TBI. This suggests that similar approaches, like NEUROBALANCE Training, might also be effective. ^{1 2 3 4 5}

Is Robotic Balance Training + Brain Stimulation safe for humans?

The research articles provided do not directly address the safety of Robotic Balance Training + Brain Stimulation for traumatic brain injury, but they do explore related therapies like virtual reality and treadmill training, vestibular rehabilitation, and translingual neurostimulation, which are generally considered safe in humans. ^{1 3 4 6 7}

How is the NEUROBALANCE Training treatment different from other treatments for traumatic brain injury?

NEUROBALANCE Training is unique because it combines robotic balance training with brain stimulation to specifically target and improve balance mechanisms that are often impaired in individuals with traumatic brain injury. This approach is different from traditional therapies as it focuses on enhancing both anticipatory and compensatory postural responses, which are crucial for maintaining balance. ^{3 5 8 9 10}

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.

Research Team

Vikram Shenoy Handiru, Ph.D.

Principal Investigator

Kessler Foundation

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 can walk at least 10 meters with or without help.

Not planning to change medication in the next four months

I was diagnosed with a mild brain injury over six months ago.

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.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors associated with balance deficits on admission to rehabilitation after traumatic brain injury: a multicenter analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Identification of static and dynamic postural instability following traumatic brain injury. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of virtual reality and treadmill training in traumatic brain injury: a randomized controlled pilot trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Translingual Neurostimulation for the Treatment of Chronic Symptoms Due to Mild-to-Moderate Traumatic Brain Injury. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Enhancing Anticipatory and Compensatory Postural Responses to Improve Balance in Individuals with TBI. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of augmenting traditional rehabilitation with audio biofeedback in people with persistent imbalance following mild traumatic brain injury. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Central sensorimotor integration assessment reveals deficits in standing balance control in people with chronic mild traumatic brain injury. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Robot-assisted therapy for balance function rehabilitation after stroke: A systematic review and meta-analysis. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Improvements in balance control in individuals with PCS detected following vestibular training: A case study. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Spectral analysis of centre of pressure identifies altered balance control in individuals with moderate-severe traumatic brain injury. [2021]