Treatment to improve heart rate variability for long-term concussion symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled trial uses a mechanism-driven behavioral intervention—heart rate variability biofeedback (HRV-B)—to target autonomic nervous system dysfunction that may perpetuate persistent post-concussion symptoms (PPCS). Adults with prior mild TBI and significant PPCS (including military veterans and service members) are randomized to receive HRV-B versus control and followed using symptom inventories, sleep measures, HRV metrics, and global impression scales. The intervention is non-invasive, rapidly deployable, and designed to improve autonomic balance, sleep, cognitive function, and psychological health. Secondary aims include exploring effects on readiness and resilience and potential implications for longer-term neurodegenerative risk after TBI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Any TBI with severity greater than mild (i.e., Moderate or Severe TBI defined as initial injury loss of consciousness (LOC) duration \>30 minutes, posttraumatic amnesia (PTA) duration \>24 hours, or traumatic hemorrhage on head computerized tomography (CT) and determined by the study investigator based on information gathered during administration of the study's validated TBI structured interview instrument.
* Conditions or medications that can affect HRV measurement (pacemaker or an implant that stimulates your heart (e.g., cardioverter-defibrillator or ICD); heart transplant or heart surgery within the last year, including bypass or other surgery, but not including a stent)
* Hx of stroke
* Mental conditions that may impede adherence (e.g., dementia, psychotic disorder, panic disorder)

Where it's running

• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: James Burch — Virginia Commonwealth University
• Study coordinator: Brett Brooks
• Email: bret.brooks@vcuhealth.org
• Phone: (804) 827-9692

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving thinking after a concussion using gentle brain stimulation plus cognitive training

  This trial will test whether pairing a mild, non-invasive brain stimulation (tDCS) with cognitive training can help adults who still have thinking problems 3–12 months after a mild concussion.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07246993

• Personalized brain stimulation for long-term symptoms after concussion

  This study will try personalized, noninvasive brain stimulation (TMS) to reduce dizziness, headaches, memory problems, and other lasting symptoms in adults aged 18–65 after a concussion.

  Recruiting Phase 2 University of California, Los Angeles · Westwood, Los Angeles, California · NCT06073886

• Combining brain stimulation with cognitive training for mild traumatic brain injury

  This study is testing whether combining brain stimulation with attention training can help people with mild traumatic brain injury and PTSD improve their focus and attention.

  Recruiting Northwestern University · Chicago, Illinois and 1 other locations · NCT03819608

• Anger, Social Thinking, and PTSD in French Veterans

  This study tests whether PTSD in former French military personnel is linked to higher anger through changes in social thinking abilities.

  Recruiting Direction Centrale du Service de Santé des Armées · Draguignan · NCT07851090

• TSND-201 treatment for PTSD in adults

  This study tests two doses of TSND-201 or placebo to see if it helps adults with PTSD.

  Recruiting at 9 sites Phase 3 Transcend Therapeutics · Denver, Colorado and 8 other locations · NCT07836647

• Long-term outcomes after Hyperbaric Oxygen Therapy in veterans with TBI, PCS, or PTSD

  This study tests whether benefits from HBOT persist over time for veterans with brain injury or related conditions.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07732374

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.