TBINCT01749800
Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors
A study testing GVS and Armeo Spring in people with TBI and Attention Deficits, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- TBI, Attention Deficits, Motor Impairments
- What is being tested?
- GVS and Armeo Spring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
Official title: Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits
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.
Read the 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.
- Conditions
- TBI, Attention Deficits, Motor Impairments
- Being tested
- GVS, Sham GVS, Armeo Spring
- Keywords
- TBI, Attention deficits, Upper extremity weakness
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GVSDevice
Also called Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA
A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
Sham GVSDevice
Also called Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USA
Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
Armeo SpringDevice
Also called Device: Armeo Spring, Produced by: Hocoma
A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Sham GVS; Device: Armeo Spring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and end-of-treatment data (up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TBIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749800
- Sponsor's protocol ID
- 2010-P-000010
- Status last verified
- Apr 2017
- First submitted
- 12 Dec 2012
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors With Attentional Deficits
- ClinicalTrials.gov ID
- NCT01749800
- Acronym / sponsor ID
- 2010-P-000010
- Conditions
- TBI, Attention Deficits, Motor Impairments
- Keywords
- TBI, Attention deficits, Upper extremity weakness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive test with/without GVS | Experimental | Device: GVS, Device: Sham GVSSubjects 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. |
| Armeo Spring +GVS | Active comparator | Device: GVS, Device: Armeo SpringSubjects 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. |
| Armeo Spring + sham GVS | Sham comparator | Device: Sham GVS, Device: Armeo SpringSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GVSAlso: Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USAA small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes. | Device | Armeo Spring +GVS, Cognitive test with/without GVS |
| Sham GVSAlso: Device: Model 2200 Analog Stimulus Isolator, Produce by: A-M Systems, Inc., WA, USAElectrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active. | Device | Armeo Spring + sham GVS, Cognitive test with/without GVS |
| Armeo SpringAlso: Device: Armeo Spring, Produced by: HocomaA robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises. | Device | Armeo Spring + sham GVS, Armeo Spring +GVS |
Primary outcome
Sustained Attention to Response Task
Time frame: Baseline and end-of-treatment data (up to 2 weeks)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GVS and Armeo Spring in people with TBI and Attention Deficits, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Attention to Response Task (time frame: Baseline and end-of-treatment data (up to 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.