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Improvement in Sleep Symptomatology and Neurocognitive Function Using Photobiomodulation in Post-Concussion Patients

NCT05072743 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-30

No results posted yet for this study

Summary

The emphasis on this study is to review the use of PBMT as a potential treatment modality to improve both sleep symptoms and consequent neuropsychological functions affected by sleep disturbances in a cohort of post-mTBI patients with sleep issues not secondary to sleep apnea.

Conditions

  • Post-Concussion Syndrome
  • Sleep Disorder

Interventions

DEVICE

Photobiomodulation Therapy

PBMT will be applied to the cervical spine using the BIOFLEX® DUO+ system that utilizes a Light Emitting Diode (LED) array pad followed by laser probes. Both delivery methods will be applied to the cervical spine and will entail the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided twice per week for 6 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for the treatment of the cervical spine soft tissue injuries.

Sponsors & Collaborators

  • Meditech Rehabilitation Centre

    collaborator OTHER

  • Michael Zitney

    lead OTHER

Principal Investigators

  • Alan Lowe, MD · Meditech International

  • Michael Zitney, MD · MediTech International Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-20
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05072743 on ClinicalTrials.gov