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NCT02383472 · ClinicalTrials.gov registry record · NA
LED Therapy for the Treatment of Concussive Brain Injury
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 53
- Enrollment target
NCT02383472: Completed NA study, sponsored by Boston Children's Hospital.
NCT02383472 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 53 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02383472, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 53 participants
- Enrollment target
Study Summary
A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo therapy (controls) or treatment with LED therapy (cases). Both cases and controls would complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms resolve before the end of the 6 week period.
Primary Outcome
The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. Th
Interventions
- DEVICE MedX Health Console model 1100
- DEVICE MedX Health Console model 1100-placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-05 |
| Phase | NA |
What the finished NCT02383472 record still lists
NCT02383472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which MedX Health Console model 1100 is the first listed.
NCT02383472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02383472 about?
NCT02383472 is a clinical study titled "LED Therapy for the Treatment of Concussive Brain Injury". A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo therapy (controls) or trea...
What is the current status of trial NCT02383472?
This trial is currently completed. It is a NA study. The enrollment target is 53 participants. The study started on 2012-09. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02383472?
The interventions under investigation include: MedX Health Console model 1100 (DEVICE), MedX Health Console model 1100-placebo (DEVICE).
Who is sponsoring clinical trial NCT02383472?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02383472's enrollment target sits among peer trials
53 1271st of 2000 higher than 729 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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