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

NCT01404494 | Completed

• 2 other identifiers: 11013711-CC-0137
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Brain Injury

Keywords

Haptic Skills; Computer Assisted Interface; TBI; Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Aisen ML, Krebs HI, Hogan N, McDowell F, Volpe BT. The effect of robot-assisted therapy and rehabilitative training on motor recovery following stroke. Arch Neurol. 1997 Apr;54(4):443-6. doi: 10.1001/archneur.1997.00550160075019.

  PMID: 9109746 BACKGROUND

• Broeren J, Rydmark M, Sunnerhagen KS. Virtual reality and haptics as a training device for movement rehabilitation after stroke: a single-case study. Arch Phys Med Rehabil. 2004 Aug;85(8):1247-50. doi: 10.1016/j.apmr.2003.09.020.

  PMID: 15295748 BACKGROUND

• Broeren J, Sunnerhagen KS, Rydmark M. A kinematic analysis of a haptic handheld stylus in a virtual environment: a study in healthy subjects. J Neuroeng Rehabil. 2007 May 9;4:13. doi: 10.1186/1743-0003-4-13.

  PMID: 17490470 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 28, 2011
• Study Start: April 5, 2011
• Study Completion: February 6, 2015
• Last Updated: July 2, 2017

Record last verified: 2015-02-06

Locations

US (1)