Clinical trial NCT01749800: Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors
Official title: Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: TBI
Attention Deficits
Motor Impairments
Keywords: TBI
Attention deficits
Upper extremity weakness
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Attention to Response Task
timeFrame: Baseline and end-of-treatment data (up to 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: