Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

Spaulding Rehabilitation Hospital7 enrolled

Overview

The overall goal of the proposed project is to perform a preliminary study to assess the potential effects of galvanic vestibular stimulation (GVS) on the outcomes of a cognitive test of attention and the outcomes of robot-assisted upper-limb rehabilitation.

We plan to explore the use of GVS on the severity of attention span deficits and motor training delivered using a spring-based robot. We intend to carry out the study in a small cohort of traumatic brain injury (TBI) survivors (20 subjects). Subjects with attention span deficits but no significant motor impairments will solely undergo a cognitive test of attention with/without GVS. Subjects with both attention span deficits and significant motor impairments will undergo a cognitive test of attention and robot-assisted upper-limb rehabilitation with/without GVS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

TBI Attention Deficits Motor Impairments

Interventions

GVSDEVICE

A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Sham GVSDEVICE

Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

Armeo SpringDEVICE

A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe traumatic brain injury involving cognitive and/or motor deficits. * Neurological injury \>1 year prior to study enrollment * Significant attention deficit * For subjects with motor deficits (arms 2 and 3), sufficient voluntary movement and range of motion in the most-affected upper extremity to use the robotic arm system (Armeo Spring) Exclusion Criteria: * Pregnancy * History of seizures within 6 months of study enrollment * Major depression * Cognitive impairment that may interfere with understanding instructions * Severe limitations of upper extremity range of motion * Agitation * Other major neurological or psychiatric diseases * Participation in other forms of therapy/ intervention for upper extremity motor recovery * End-stage liver, kidney, cardiac or pulmonary disease * A terminal medical diagnosis with survival \<1 year * History of drug or alcohol abuse in the last 3 years * Adjustment of, or plan to adjust, psychoactive medications within the preceding 1 month, or within the study period. * Current participation in another interventional trial targeting TBI * Previous GVS treatment * Contraindications to GVS such as implants

Locations (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Sustained Attention to Response Task

Subjects are presented with objects (one at the time) on a computer screen and are instructed to press a key on the keyboard according to the characteristics of the object shown on the computer screen. Error rates are measured as percentage of erroneous key selections.

Time frame: Baseline and end-of-treatment data (up to 2 weeks)

Data from ClinicalTrials.gov

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