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NCT01725750 · ClinicalTrials.gov registry record · NA

Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy

A NA study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
88
Enrollment target

NCT01725750: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT01725750 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01725750, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
88 participants
Enrollment target

Study Summary

This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report significant reductions in fatigue compared to individuals receiving dim red light treatment for the same duration of time, and that these treatment effects will be maintained one month after treatment completion.

Primary Outcome

Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.

Interventions

  • DEVICE Bright White Light (BWL)
  • DEVICE Dim Red Light (DRL)

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2012-11
Est. Completion 2017-06
Phase NA

What the finished NCT01725750 record still lists

NCT01725750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Bright White Light (BWL) is the first listed.

NCT01725750 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01725750 about?

NCT01725750 is a clinical study titled "Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy". This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report sign...

What is the current status of trial NCT01725750?

This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2012-11. Estimated completion is 2017-06.

What interventions are being tested in trial NCT01725750?

The interventions under investigation include: Bright White Light (BWL) (DEVICE), Dim Red Light (DRL) (DEVICE).

Who is sponsoring clinical trial NCT01725750?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01725750's enrollment target sits among peer trials

88 972nd of 2000 higher than 1,027 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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Source: ClinicalTrials.gov NCT01725750, the US trial registry maintained by the National Library of Medicine. NCT01725750 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.