Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors
NCT ID: NCT01749800
Last Updated: 2017-05-31
Study Results
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View full resultsBasic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2011-07-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive test with/without 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.
GVS
A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Sham GVS
Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo Spring +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.
GVS
A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Armeo Spring
A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
Armeo Spring + 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.
Sham GVS
Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo Spring
A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
Interventions
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GVS
A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Sham GVS
Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo Spring
A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Spaulding Rehabilitation Hospital
OTHER
Responsible Party
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Paolo Bonato
Director, Motion Analysis Lab
Principal Investigators
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Paolo Bonato, PhD
Role: PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital
Locations
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Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2010-P-000010
Identifier Type: -
Identifier Source: org_study_id
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