Effects of LEDs on Memory in TBI Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01598532
First received: May 4, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.


Condition Intervention
Traumatic Brain Injury
Device: MedX Health Phototherapy (light and laser therapy)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study

Resource links provided by NLM:


Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Neuropsychological Test Battery (outcome Measures) [ Time Frame: 4 months in duration ] [ Designated as safety issue: No ]
    The Neuropsychological Test Battery will be at pre-LED Treatment (prior to intervention begins) for Baseline results. Neuropsychological Test Battery will be at repeated at 1 week, 1 month and 2 months following end of LED treatments to look for changes from Baseline results. The primary outcome metric is change in the Test Battery


Enrollment: 14
Study Start Date: September 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MedX Health Phototherapy (light and laser therapy)
    The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
Detailed Description:

This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury.

Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, Ages 18-65
  • sustained a mild traumatic brain injury(mTBI) at least 6 months ago
  • mTBI is defined as < 30 minutes loss of consciousness and <30 minutes, post trauma amnesia
  • since the injury patient continues having problems with memory and thinking ability

Exclusion Criteria:

  • Younger than 18 or older than 65
  • mTBI occured less than 6 months ago
  • moderate to severe Traumatic Brain Injury (TBI)
  • non-closed head injury
  • presence of craniotomy, craniectomy, or ventriculoperitoneal shunt
  • Non-English speaking subjects - Neuropsychological Tests only in English
  • Neuropsychological Screening Test Scores not at least 2 SD below norm on one of the neuropsychological tests or not 1 SD below norm on at least two of the tests administered during screening)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598532

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Ross D Zafonte, DO Spaulding Rehabilitation Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Ross D. Zafonte, MD, Vice President Medical Affairs, Research and Education Spaulding Rehabilitation Network, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01598532     History of Changes
Other Study ID Numbers: 2009-P-001552
Study First Received: May 4, 2012
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
mild traumatic brain injury
mild TBI
mTBI

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 26, 2014