Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

NCT01749800 | Terminated Results

• 1 other identifier: 2010-P-000010
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI; Attention Deficits; Motor Impairments

Keywords

TBI; Attention deficits; Upper extremity weakness

Outcome Measures

Primary Outcomes (1)

• Sustained Attention to Response Task

  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.

  Baseline and end-of-treatment data (up to 2 weeks)

Study Arms (3)

Cognitive test with/without GVS

EXPERIMENTAL

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.

Device: GVS; Device: Sham GVS

Armeo Spring +GVS

ACTIVE COMPARATOR

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.

Device: GVS; Device: Armeo Spring

Armeo Spring + sham GVS

SHAM COMPARATOR

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.

Device: Sham GVS; Device: Armeo Spring

Interventions

GVS DEVICE

A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.

Also known as: Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA

Armeo Spring +GVS; Cognitive test with/without GVS

Sham GVS DEVICE

Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.

Also known as: Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA

Armeo Spring + sham GVS; Cognitive test with/without GVS

Armeo Spring DEVICE

A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.

Also known as: Device: Armeo Spring, Produced by: Hocoma

Armeo Spring + sham GVS; Armeo Spring +GVS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Paresis

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paolo Bonato
• Organization: Spaulding Rehabilitation Hospital

pbonato@partners.org

+1-617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Lab

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: July 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)