Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

Not Applicable

Terminated

• Conditions: Motor Impairments; TBI; Attention Deficits
• Interventions: Device: Sham GVS; Device: GVS; Device: Armeo Spring

• Registration Number: NCT01749800
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

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

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2017-03-19
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-30
• Last Update Submitted: 2017-04-30
• Results First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Armeo Spring + sham GVS	Sham GVS	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.
Cognitive test with/without GVS	Sham GVS	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.
Armeo Spring +GVS	Armeo Spring	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.
Armeo Spring + sham GVS	Armeo Spring	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.
Cognitive test with/without GVS	GVS	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.
Armeo Spring +GVS	GVS	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.

Primary Outcome Measures

Name	Time	Method
Sustained Attention to Response Task	Baseline and end-of-treatment data (up to 2 weeks)	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.

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States