Testing Devices That Involve the Sense of Touch in Subjects With Traumatic Brain Injury
|ClinicalTrials.gov Identifier: NCT01404494|
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : July 2, 2017
|First Submitted Date||July 27, 2011|
|First Posted Date||July 28, 2011|
|Last Update Posted Date||July 2, 2017|
|Study Start Date||April 5, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01404494 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Testing Devices That Involve the Sense of Touch in Subjects With Traumatic Brain Injury|
|Official Title||Testing Subjects With Traumatic Brain Injury Using Haptic Technology|
- 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.
- To evaluate the effectiveness of a computer-based simulation compared with actual performance of actions in individuals who have had a traumatic brain injury.
- 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.
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.
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.
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.
Performance on haptic tasks will be assessed for time to completion, distance of trajectories and frequency of repeated trajectories.
|Study Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition||Traumatic Brain Injury|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||February 6, 2015|
|Primary Completion Date||Not Provided|
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
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
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||110137
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC)|
|Study Sponsor||National Institutes of Health Clinical Center (CC)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 6, 2015|