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

NCT06584591 | Recruiting FDA Device

• 1 other identifier: R-1261-24
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury; TBI; Diffuse Axonal Brain Injury; Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  A widely used outcome measure of static standing balance function (Newstead et al., 2005), categorized under the 'Activity' subsection of ICF domain. BBS scores range from 0 to 56 (the higher, the better). The change in BBS scores from baseline to 4 weeks post-training will be the primary endpoint.

  Baseline, post 4-week training, 2-month follow-up

Secondary Outcomes (11)

• Functional Gait Assessment (FGA)

  Baseline, post 4-week training, and 2-month follow-up

• Mini Balance Evaluation Systems Test (MBT)

  Baseline, post 4-week training, and 2-month follow-up

• Trunk Impairment Scale (TIS)

  Baseline, post 4-week training, and 2-month follow-up

• Center of Pressure (COP) Displacement

  Baseline, post 4-week training, and 2-month follow-up

• TMS-evoked EEG Potentials (TEP)

  Baseline, post 4-week training, and 2-month follow-up

Study Arms (3)

RBT + Active HD-tDCS Group

EXPERIMENTAL

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.

Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation)

RBT + Sham HD-tDCS Group

SHAM COMPARATOR

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.

Device: Combined (Robotic balance training and high-definition transcranial direct current stimulation)

SOC Control Group

OTHER

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

Other: Standard of Care Balance Training

Interventions

Combined (Robotic balance training and high-definition transcranial direct current stimulation) DEVICE

The robotic platform will train the participants to maintain dynamic balance in the sagittal and the transverse planes (mediolateral and anterior-posterior directions) and engage in core stability and trunk control with seated balance exercises. In addition, high-definition transcranial direct current stimulation (HD-tDCS) will be used as an adjuvant to robotic balance training by priming the corticospinal circuits.

RBT + Active HD-tDCS Group; RBT + Sham HD-tDCS Group

Standard of Care Balance Training OTHER

Participants in this group will receive a standard-of-care balance training administered by the Physical therapist.

SOC Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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).

You may not qualify 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 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• United States Department of Defense: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries, Diffuse

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Vikram Shenoy Handiru, Ph.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vikram Shenoy Handiru, Ph.D.

CONTACT

9733243578; vshenoy@kesslerfoundation.org

Kathleen Goworek, B.S.

CONTACT

kgoworek@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The mode of HD-tDCS (active/sham) will be masked for the participant and outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 5, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Six months after study completion.
• Access Criteria: "Authorized Users" (i.e., all Users with an account on the ODC-TBI) will have access to the data.

Locations

US (1)