Testing Devices That Involve the Sense of Touch in Subjects With Traumatic Brain Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2017 |
| Start Date: | April 5, 2011 |
| End Date: | February 6, 2015 |
Testing Subjects With Traumatic Brain Injury Using Haptic Technology
Background:
- Previous studies have shown that computer-based devices that simulate everyday tasks can
be helpful for evaluation and rehabilitation in people who have had strokes. Researchers are
interested in studying whether similar devices can be used to evaluate and treat individuals
who have had a traumatic brain injury, to determine if the device should be developed to
help with rehabilitation in the future.
Objectives:
- To evaluate the effectiveness of a computer-based simulation compared with actual
performance of actions in individuals who have had a traumatic brain injury.
Eligibility:
- Individuals at least 18 years of age who have had a non-penetrating mild or moderate
traumatic head injury within the past year and have experience playing computer games.
Design:
- Participants will be screened with a physical and neurological examination and medical
history.
- Participants will complete questionnaires and an interview about mood and feelings,
stress levels, quality of life, and how well they function at work or at home.
Participants will also have tests of memory, attention, thinking, and reasoning. Some
of the questionnaires and tests will be completed in writing, some orally, and some on
a computer.
- Participants will have movement and coordination tests that involve simple tasks such
as putting pegs in a pegboard, using a key, lifting different objects, and folding
things.
- Participants will duplicate the movement and coordination tests by using a computer
program that simulates the tasks with a cursor on a computer screen. Participants will
do four separate simulated tasks (such as arranging letters or hitting a nail with a
hammer) three times.
- The full visit will take about 4 hours, and no followup visits are required.
- Previous studies have shown that computer-based devices that simulate everyday tasks can
be helpful for evaluation and rehabilitation in people who have had strokes. Researchers are
interested in studying whether similar devices can be used to evaluate and treat individuals
who have had a traumatic brain injury, to determine if the device should be developed to
help with rehabilitation in the future.
Objectives:
- To evaluate the effectiveness of a computer-based simulation compared with actual
performance of actions in individuals who have had a traumatic brain injury.
Eligibility:
- Individuals at least 18 years of age who have had a non-penetrating mild or moderate
traumatic head injury within the past year and have experience playing computer games.
Design:
- Participants will be screened with a physical and neurological examination and medical
history.
- Participants will complete questionnaires and an interview about mood and feelings,
stress levels, quality of life, and how well they function at work or at home.
Participants will also have tests of memory, attention, thinking, and reasoning. Some
of the questionnaires and tests will be completed in writing, some orally, and some on
a computer.
- Participants will have movement and coordination tests that involve simple tasks such
as putting pegs in a pegboard, using a key, lifting different objects, and folding
things.
- Participants will duplicate the movement and coordination tests by using a computer
program that simulates the tasks with a cursor on a computer screen. Participants will
do four separate simulated tasks (such as arranging letters or hitting a nail with a
hammer) three times.
- The full visit will take about 4 hours, and no followup visits are required.
Adults who have suffered traumatic brain injury are people who have a wide variety of signs
and symptoms. These often include problems with motor planning and learning, memory,
cognitive performance and behavior. The physical findings and self reports of symptoms are
heterogeneous, and do not always correlate with anatomic findings. Evaluation and
measurement of function in this population, and treatment of functional deficits are being
developed so that treatments can be specifically targeted toward functional recovery.
Additionally, evaluation and treatment usually relies heavily on labor intensive
interventions. This study will assess the feasibility of using haptic devices that interface
the user via touch using force as feedback in subjects with a TBI. Haptic devices are
similar to joysticks. The specific haptic device we are using in this project is a stylus,
shaped like a pen with which the subject navigates virtual space moving a cursor on a
computer screen. The project aims to obtain pilot data in relation to how an individual with
TBI performs measuring their engagement and interaction with the haptic, which is programmed
to simulate functional activity and cognitive tasks, and whether the haptic devices can
reliably be used for data capture.
Study Population
Seventy adult subjects with a clinical diagnosis of a non-penetrating TBI will be enrolled.
Subjects will need to be at least 1 year from date of initial brain injury. Subjects will be
recruited from NIH, affiliated hospitals/clinics, and in the community.
Design
This is a prospective cohort study of subjects with a clinical diagnosis of a
non-penetrating traumatic brain injury. Subjects will be recruited and assessed at the
National Institutes of Health. Data will be shared and stored at NIH. Subjects will be
stratified according to findings into cohorts for comparison. Subjects will not be treated
with experimental therapies as part of the research study.
The role of multimodal visuo-sensory motor input learning using haptic devices will be
explored in this project. Virtual reality has been applied to both the evaluation and
treatment of persons with TBI. The application of simulated environments has helped engage
patients in therapeutic activities and also has provided real life situations that call for
integration of sensory, cognitive and motor activities Haptic and robotic devices, which
provide sensory and force input to assist in human movement, have been used to help in
neurorecovery.
Each subject will have only one test session and there will be no further follow-up
appointments. The haptic session is designed to take no more than 1 hour. However, it may
take longer for some to complete the battery of tests. It may take up to four hours to
complete the NIH processes such as admissions, the history and physical, and the haptic
session.
Outcome Measures
Performance on haptic tasks will be assessed for time to completion, distance of
trajectories and frequency of repeated trajectories.
and symptoms. These often include problems with motor planning and learning, memory,
cognitive performance and behavior. The physical findings and self reports of symptoms are
heterogeneous, and do not always correlate with anatomic findings. Evaluation and
measurement of function in this population, and treatment of functional deficits are being
developed so that treatments can be specifically targeted toward functional recovery.
Additionally, evaluation and treatment usually relies heavily on labor intensive
interventions. This study will assess the feasibility of using haptic devices that interface
the user via touch using force as feedback in subjects with a TBI. Haptic devices are
similar to joysticks. The specific haptic device we are using in this project is a stylus,
shaped like a pen with which the subject navigates virtual space moving a cursor on a
computer screen. The project aims to obtain pilot data in relation to how an individual with
TBI performs measuring their engagement and interaction with the haptic, which is programmed
to simulate functional activity and cognitive tasks, and whether the haptic devices can
reliably be used for data capture.
Study Population
Seventy adult subjects with a clinical diagnosis of a non-penetrating TBI will be enrolled.
Subjects will need to be at least 1 year from date of initial brain injury. Subjects will be
recruited from NIH, affiliated hospitals/clinics, and in the community.
Design
This is a prospective cohort study of subjects with a clinical diagnosis of a
non-penetrating traumatic brain injury. Subjects will be recruited and assessed at the
National Institutes of Health. Data will be shared and stored at NIH. Subjects will be
stratified according to findings into cohorts for comparison. Subjects will not be treated
with experimental therapies as part of the research study.
The role of multimodal visuo-sensory motor input learning using haptic devices will be
explored in this project. Virtual reality has been applied to both the evaluation and
treatment of persons with TBI. The application of simulated environments has helped engage
patients in therapeutic activities and also has provided real life situations that call for
integration of sensory, cognitive and motor activities Haptic and robotic devices, which
provide sensory and force input to assist in human movement, have been used to help in
neurorecovery.
Each subject will have only one test session and there will be no further follow-up
appointments. The haptic session is designed to take no more than 1 hour. However, it may
take longer for some to complete the battery of tests. It may take up to four hours to
complete the NIH processes such as admissions, the history and physical, and the haptic
session.
Outcome Measures
Performance on haptic tasks will be assessed for time to completion, distance of
trajectories and frequency of repeated trajectories.
- INCLUSION CRITERIA:
Subjects eligible for participation in this research study must meet the following
inclusion criteria:
Ages 18 and older
Some experience with computer games
Diagnosis of traumatic brain injury
At least 1 year from initial traumatic brain injury
Able to understand and comply with study procedures
Able to read, speak, and understand English
Capable of providing own consent
EXCLUSION CRITERIA:
Subjects are not eligible for participation in this research study if any of the following
conditions exist:
Inability to grasp and manipulate a 2 cm diameter pen like structure with preferred hand
Unable to adequately detect objects on the computer screen
Penetrating head injury
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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