Effects of LEDs on Memory in TBI Patients (LED)

August 23, 2016 updated by: Ross D. Zafonte, MD, Spaulding Rehabilitation Hospital

Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Spaulding Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial LED Treatment
All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
Device: MedX Health Phototherapy (light 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroop Test for Executive Function - Trial 3 - Inhibition
Time Frame: Baseline and 1-Week, 1-month and 2-months after final LED Treatment
Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Baseline and 1-Week, 1-month and 2-months after final LED Treatment
Stroop Test for Executive Function - Trial 4 Inhibition Switching
Time Frame: Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment
Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5
Time Frame: Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment
California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall
Time Frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Controlled Oral Word Association Test (FAS)
Time Frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Digit Span, Forwards and Backwards
Time Frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.
Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-P-001552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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