The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms

NCT03338036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-08-09

Study results available
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Summary

Most concussions resolve within 7-10 days, but approximately 40% of individuals do not fully recover and suffer from persistent post-concussive symptoms. This 8-week intervention study will evaluate the efficacy of heart rate variability (HRV) biofeedback and neurofeedback on reducing the number and severity of concussion symptoms.

Conditions

  • Post-Concussion Syndrome

Interventions

DEVICE

Heart Rate Variability Biofeedback

HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.

DEVICE

Neurofeedback

LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.

Sponsors & Collaborators

  • Parkwood Hospital, London, Ontario

    collaborator OTHER
  • Western University, Canada

    lead OTHER

Principal Investigators

  • James P Dickey, PhD · Western University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-08-31
Completion
2018-08-31
FDA Device
Yes

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 NCT03338036 on ClinicalTrials.gov