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Behavioural Intervention

Robotic Balance Training + Brain Stimulation for Traumatic Brain Injury

N/A

Waitlist Available

Led By Vikram Shenoy Handiru, Ph.D.

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Complaints of impaired balance and poor postural control determined by a BBS score of ≤50

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)

Must not have

Any other neurological injury or psychiatric conditions (e.g., severe anxiety or schizophrenia, etc.)

History of stroke or penetrating TBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post 4-week training, 2-month follow-up

Summary

"This trial, called NEUROBALANCE, will test if a combination of robotic balance training and noninvasive brain stimulation can help improve balance in individuals with chronic traumatic brain injury. 45 participants

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the brain stimulation device or fatigue from the physical demands of balance training. However, specific side effects related to this intervention are not detailed in the provided information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have trouble with balance and posture, scoring 50 or less on the BBS.

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I can understand and follow study instructions.

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

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I am between 18 and 75 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe mental health conditions like severe anxiety or schizophrenia.

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I have had a stroke or a serious brain injury.

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I had nerve, muscle, or bone issues in my legs before my brain injury.

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I have a skin condition like psoriasis or eczema on my scalp.

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I don't have metal implants in my head or a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post 4-week training, 2-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post 4-week training, 2-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post 4-week training, 2-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Berg Balance Scale (BBS)

Secondary study objectives

Center of Pressure (COP) Displacement

Dizziness Handicap Inventory (DHI)

EEG Corticocortical Functional Connectivity

+8 more

Trial Design

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

0 / 10Eligibility criteria met