Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

Stopped early · Not applicable · Has a placebo group

Conditions studied: TBI, Attention Deficits, Motor Impairments

In brief

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.

Key facts

Study ID

NCT01749800

Run by

Spaulding Rehabilitation Hospital

People needed

7

Starts

2011-07-01

Expected to finish

2014-11-01

Last updated by the study team

2017-05-31

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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