NCT01598532

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

August 22, 2016

Completed
Last Updated

September 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

May 4, 2012

Results QC Date

May 16, 2016

Last Update Submit

August 23, 2016

Conditions

Traumatic Brain Injury

Keywords

mild traumatic brain injurymild TBImTBI

Outcome Measures

Primary Outcomes (6)

  • Stroop Test for Executive Function - Trial 3 - Inhibition

    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

    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

    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

    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)

    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

    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

Study Arms (1)

Transcranial LED Treatment

EXPERIMENTAL

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)

Interventions

MedX Health Phototherapy (light therapy)DEVICE

The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.

Transcranial LED Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Hashmi JT, Huang YY, Osmani BZ, Sharma SK, Naeser MA, Hamblin MR. Role of low-level laser therapy in neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S292-305. doi: 10.1016/j.pmrj.2010.10.013.

    PMID: 21172691RESULT

  • Naeser MA, Saltmarche A, Krengel MH, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011 May;29(5):351-8. doi: 10.1089/pho.2010.2814. Epub 2010 Dec 23.

    PMID: 21182447RESULT

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain Concussion

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

Small sample size \& Open Protocol

Results Point of Contact

Title
Ross D. Zafonte, DO
Organization
Spaulding Rehabilitation Hospital
rzafonte@partners.org
617-952-5227

Study Officials

  • Ross D Zafonte, DO

    Spaulding Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President Medical Affairs, Research and Education Spaulding Rehabilitation Network

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 15, 2012

Study Start

September 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 30, 2016

Results First Posted

August 22, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)