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

Virginia Commonwealth University (VCU)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Persistent Post Concussion Syndrome; Concussive Injury; Post Traumatic Stress Disorder; Mild Traumatic Brain Injury; Autonomic Nervous System Disease

Treatments: Behavioral: Pittsburgh Sleep Quality Index (PSQI); Other: Psychoeducational (Edu) Comparator Intervention; Behavioral: Cognitive Performance/NIH Toolbox Cognitive Battery; Behavioral: NSI; Behavioral: Patient Global Impression of Change (PGIC); Other: Pain Interference/TBI-QoL Pain Interference Short-Form; Behavioral: Patient Health Questionnaire-9 (PHQ-9); Other: HRV Biofeedback (HRV-B); Behavioral: Quantitative Sleep Measures; Other: HRV Coherence Ratio; Behavioral: PTSD Checklist for DSM-5 (PCL-5)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07071350

HM20031279

Details and patient eligibility

About

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

Full description

This study, a randomized, controlled trial (RCT) of an easily implemented, mechanism-driven, behavioral intervention using HRV biofeedback (HRV-B) to treat PPCS among adults, including c-Vs and SMs, with history of single or repeated mTBI from blast-related or other mechanism. Specifically, we study an intervention for persons with PPCS that promotes sustained functional recovery during the chronic phase of injury, which addresses psychological health and cognitive functioning, and has the potential to address neurodegenerative processes associated with TBI and treat co-occurring TBI and psychological health conditions. Importantly, the intervention is non-invasive, rapidly deployable, and is based on the pathophysiology and a theoretical mechanism of PPCS. Secondarily, this project also has the potential as a more generalized solution to increase readiness and psychological resilience in individuals, small teams, families, and communities to ameliorate the potential negative impacts of specific military and life stressors.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Heart rate variability biofeedback (HRV-B)

Experimental group

Description:

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.

Treatment:

Behavioral: PTSD Checklist for DSM-5 (PCL-5)

Other: HRV Coherence Ratio

Behavioral: Quantitative Sleep Measures

Other: HRV Biofeedback (HRV-B)

Behavioral: Patient Health Questionnaire-9 (PHQ-9)

Other: Pain Interference/TBI-QoL Pain Interference Short-Form

Behavioral: Patient Global Impression of Change (PGIC)

Behavioral: NSI

Behavioral: Cognitive Performance/NIH Toolbox Cognitive Battery

Behavioral: Pittsburgh Sleep Quality Index (PSQI)

Education

Experimental group

Description:

Psychoeducational treatment

Treatment:

Behavioral: PTSD Checklist for DSM-5 (PCL-5)

Other: HRV Coherence Ratio

Behavioral: Quantitative Sleep Measures

Behavioral: Patient Health Questionnaire-9 (PHQ-9)

Other: Pain Interference/TBI-QoL Pain Interference Short-Form

Behavioral: Patient Global Impression of Change (PGIC)

Behavioral: NSI

Behavioral: Cognitive Performance/NIH Toolbox Cognitive Battery

Other: Psychoeducational (Edu) Comparator Intervention

Behavioral: Pittsburgh Sleep Quality Index (PSQI)