Not provided
Not provided
Not provided
Not provided
Not provided
Lack of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GVS | Device | A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | percentage errors | Baseline and end-of-treatment data (up to 2 weeks) |
|
Data was collected through study completion (i.e. up to two weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin damage caused on the stimulation electrodes | General disorders | Systematic Assessment | Delivering a small current through the skin could cause skin damage in the areas covered by the stimulation electrodes. We inspected the skin under the electrodes multiple times during the experiments to monitor the skin status. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation caused by the straps of the robot | General disorders | Systematic Assessment | The robotic system used to facilitate motor training is equipped with straps that are attached to the arm of the subject. The straps could cause skin irritation. The "cognitive test" group did not use the robotic system. Thus, no subject was at risk. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paolo Bonato | Spaulding Rehabilitation Hospital | +1-617-952-6319 | pbonato@partners.org |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham GVS | Device | Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active. |
|
|
| Armeo Spring | Device | A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises. |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Mean | Full Range | percentage error |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 0 |
| 6 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 1 | 0 | 1 |
| EG002 | 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. | 0 | 0 | 0 | 0 |
|
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |