What side effects are associated with this type of intervention?

Blood flow restriction training, used to enhance exercise gains in patients with PCS, is generally well-tolerated but may cause mild discomfort or muscle soreness. Other common treatments for PCS include physical and cognitive rest, which typically have no side effects but may lead to deconditioning if prolonged. Pharmacologic treatments like NSAIDs for headache management can cause gastrointestinal upset or rebound headaches with prolonged use. Vestibular rehabilitation for dizziness is usually safe but may initially exacerbate symptoms. Overall, these treatments are considered safe with manageable side effects.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved drugs for the treatment of Post-Concussion Syndrome (PCS). Treatment typically focuses on symptom management, including medications for headaches, sleep disturbances, and mood disorders. The Blood Flow Restriction Training (BFRT) being studied for PCS aims to facilitate autonomic responses similar to high load training, which is a novel approach and not yet FDA-approved. Traditional treatments for PCS do not include BFRT or similar autonomic response facilitation methods.

What other types of research exist?

Promising novel alternatives to Blood Flow Restriction Training for Post-Concussion Syndrome patients include mindfulness-based yoga and non-invasive vagus nerve stimulation (nVNS). Both approaches have shown potential in facilitating autonomic responses and improving symptoms in neurological conditions.

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Blood Flow Restriction Training for Post-Concussion Syndrome

N/A

Waitlist Available

Led By Laura Pietrosimone

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Post-Concussion Syndrome (medical diagnosis of concussion with symptoms lasting greater than four weeks)

Ages 14-30 years old

Must not have

Exclusion criteria for Blood Flow Restriction (open wounds or fracture, history of clot, impaired circulation or venous compromise, sickle cell anemia, extremity infection, tumor distal to tourniquet placement, cancer, lymphectomy)

Focal neurological deficits

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week, 3 weeks, 6 weeks, 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if Blood Flow Restriction (BFR) training can help patients aged 14-30 with symptoms after a concussion exercise more effectively. BFR uses a cuff to limit blood flow, making light exercises feel more intense. This could help these patients gain the benefits of exercise without worsening their symptoms. Blood Flow Restriction (BFR) training has been used to increase strength and muscle mass in various populations, including those with chronic conditions like multiple sclerosis and Parkinson's disease.

Who is the study for?

This trial is for English-speaking individuals aged 14-30 with Post-Concussion Syndrome, experiencing symptoms over four weeks and worsened by physical activity. It's not suitable for those with open wounds, clot history, circulation issues, sickle cell anemia, infections near the tourniquet area, cancer or lymph removal.

What is being tested?

The study tests if blood flow restriction training combined with low load exercise can help concussion patients who struggle with regular exercises. The goal is to see if this method can produce benefits similar to high load training without worsening concussive symptoms.

What are the potential side effects?

While blood flow restriction is generally safe and used in various conditions at Duke Sports Physical Therapy, potential side effects may include discomfort at the tourniquet site or temporary changes in skin coloration and sensation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Post-Concussion Syndrome.

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I am between 14 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have open wounds, clots, poor circulation, sickle cell, infections near the tourniquet area, cancer, or have had a lymphectomy.

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I have specific areas of weakness or loss of function.

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I have been diagnosed with vertigo that comes and goes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week, 3 weeks, 6 weeks, 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week, 3 weeks, 6 weeks, 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 3 weeks, 6 weeks, 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Post Concussion Symptom Score

Secondary study objectives

Change in Global Function Rating

Change in Heart Rate Variability

Change in Presence of Orthostatic Symptoms (Headache)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Without BFR THEN with BFRExperimental Treatment1 Intervention

Will perform exercises without BFR at the first visit and with BFR at the second visit

Group II: BFR THEN without BFRExperimental Treatment1 Intervention

Will perform exercises with BFR at the first visit and without BFR at the second visit

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Post-Concussion Syndrome (PCS) treatments often include graded exercise therapy, vestibular physiotherapy, and cognitive-behavioral therapy. Graded exercise therapy, similar to Blood Flow Restriction Training (BFRT), works by gradually increasing physical activity to improve autonomic regulation and reduce exercise intolerance. Vestibular physiotherapy targets balance and dizziness issues by retraining the vestibular system. Cognitive-behavioral therapy addresses the psychological aspects of PCS, such as anxiety and depression, by modifying thought patterns and behaviors. These treatments are crucial for PCS patients as they help restore normal function, reduce symptoms, and improve overall quality of life.

Physical Activity and Intermittent Postconcussion Symptoms After a Period of Symptom-Limited Physical and Cognitive Rest.