NCT01404494

Testing Devices That Involve the Sense of Touch in Subjects With Traumatic Brain Injury

Completed Last updated 2 July 2017

What this trial tests

trial in Traumatic Brain Injury in 19 participants. Completed in 6 February 2015.

Timeline

5 April 2011

6 February 2015

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	19
Start date	5 April 2011
Estimated completion	6 February 2015
Sites	1 location across United States

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

18 and older, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.