Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits

Conditions
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TBI, Attention Deficits, Motor Impairments

Intervention / Treatment
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* Device: GVS
* Device: Sham GVS
* Device: Armeo Spring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive test with/without GVS<br>Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems. | Device: GVS<br>* A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.<br>* Other names: Produce by: A-M Systems, Inc., WA, USA;Device: Sham GVS<br>* Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.<br>* Other names: Produce by: A-M Systems, Inc., WA, USA;|
| Active Comparator: Armeo Spring +GVS<br>Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems. | Device: GVS<br>* A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.<br>* Other names: Produce by: A-M Systems, Inc., WA, USA;Device: Armeo Spring<br>* A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.<br>* Other names: Produced by: Hocoma;|
| Sham Comparator: Armeo Spring + sham GVS<br>Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active. | Device: Sham GVS<br>* Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.<br>* Other names: Produce by: A-M Systems, Inc., WA, USA;Device: Armeo Spring<br>* A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.<br>* Other names: Produced by: Hocoma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and end-of-treatment data (up to 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Attention deficits, Upper extremity weakness