Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Many combat veterans (c-Vs), service members (SMs) and civilians with mild traumatic brain injury (mTBI, also termed concussion) suffer from persistent post-concussion symptoms (PPCS) that degrade physical and cognitive well-being and have been linked with early neurodegeneration. PPCS include somatosensory (e.g., headache, disturbed vision), vestibular (e.g., dizzy, clumsy), cognitive (e.g., executive function, memory) and affective symptoms (e.g., sleep disturbance, irritability, depression). A key pathological process that provokes and perpetuates PPCS is autonomic nervous system (ANS) dysfunction such as unremitting sympathetic nervous system activation that also exacerbates other pathology such as inflammation. ANS activity can be readily quantified by measuring heart rate variability (HRV), or the variation in heart rate over time, which serves as a valid index of both physiological and psychological health

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age 18 or older

• History of military service

• Self-Reported hx of 1 or more mild TBI

• Most recent TBI more than 1 year ago

• Significant Persistent Post-Concussion Symptom burden (Neurobehavioral Symptom Inventory \[NSI\] total score greater than or equal to 20).

• Current Sleep Difficulties

• Fluent English

• Able to provide Informed Consent

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Brett Brooks
bret.brooks@vcuhealth.org
(804) 827-9692
Backup
Jennifer Weggen
weggenj@vcu.edu
8048279692
Time Frame
Start Date: 2025-09-02
Estimated Completion Date: 2028-09
Participants
Target number of participants: 148
Treatments
Experimental: Heart rate variability biofeedback (HRV-B)
Behavioral intervention using HRV biofeedback (HRV-B) to treat Persistent Post-Concussion Symptoms (PPCS) among adults, including Combat Veterans (c-Vs) and Service Members (SMs), with history of single or repeated mTBI from blast-related or other mechanism.
Experimental: Education
Psychoeducational treatment
Sponsors
Collaborators: United States Department of Defense
Leads: Virginia Commonwealth University

This content was sourced from clinicaltrials.gov