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

TBI Clinical Trial

— GVS TBI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749800
• Other study ID #: 2010-P-000010
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: November 20, 2014
• Start date: July 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The overall goal of the proposed project is: (1) to perform a preliminary study to determine optimal galvanic vestibular stimulation (GVS) settings based on performance of one cognitive test of attention, and (2) to gather preliminary evidence of the effects of GVS in combination with computer-based attention training and motor training performed using a robotic system designed for rehabilitation, in a small cohort of TBI survivors (20 subjects).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

• Sufficient voluntary movement and range of motion in their upper extremity to use the robotic arm system (ARMEO)

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficits
• Brain Injuries
• TBI

Intervention

Device:
• GVS

• Sham GVS

• Armeo Spring

Other:
• Computer-based attention games

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Jebsen-Taylor Hand Function Test scores from Baseline		Baseline, week 4, 2 weeks follow-up (week 6)	No
Primary	Changes in Box and Block Test scores from Baseline		Baseline, week 4, 2 weeks follow-up (week 6)	No