Targeted Multidomain Intervention for Concussion

(T-MD Trial)

Recruiting at 1 trial location

Overseen By Anthony P Kontos, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Vestibular disorder, Neurological disorder, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

169 Participants Needed

Trial Summary

What is the purpose of this trial?

Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Targeted Multidomain Intervention for Concussion?

Research suggests that a multidisciplinary approach, which includes psychoeducation (teaching about the condition) and cognitive strategy instruction (teaching ways to improve thinking skills), can help manage prolonged concussion symptoms by improving attention, memory, and daily functioning. ^{1 2 3 4 5}

How is the Targeted Multidomain Intervention for Concussion treatment different from other treatments?

The Targeted Multidomain Intervention for Concussion is unique because it uses a personalized, dynamic approach tailored to each individual's symptoms, focusing on psychoeducation and cognitive strategy instruction to address cognitive impairments. This treatment adapts based on the patient's progress and perceived helpfulness of strategies, making it more flexible and responsive compared to standard treatments. ^{1 3 4 6 7}

Research Team

Anthony P Kontod, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for military-aged civilians (18-49) who've had a mild traumatic brain injury (mTBI) with symptoms like confusion, dizziness, or memory issues. They must have been diagnosed within the past 8 days to 6 months and have a Glascow coma scale score of at least 13. Exclusions include those with certain vestibular or neurological disorders, severe TBI history, pregnancy, legal actions related to mTBI, or previous participation in this study.

Inclusion Criteria

I have complex symptoms from a brain injury in areas like mood, thinking, or sleep.

I have experienced symptoms like confusion, dizziness, or memory problems possibly due to a mild brain injury.

You must have a Glascow coma scale (GCS) score of at least 13.

Exclusion Criteria

I haven't been treated at the study sites in the last 2 years.

Currently on workman's compensation

I have been diagnosed with heart, blood vessel, or brain blood flow problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Comprehensive multidomain evaluation of symptoms and impairment to inform adjudication process

1 week

1 visit (in-person)

Treatment

Participants receive targeted multidomain interventions or usual care for complex mTBI

4 weeks

4 visits (in-person), at-home activities

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

3 visits (in-person)

Treatment Details

Interventions

• Behavioral Management
• Targeted Multidomain

Trial Overview The study compares targeted multidomain interventions focusing on areas such as anxiety/mood, cognitive functions, migraines etc., against usual behavioral management care. It's designed to see if these specialized treatments are more effective for people with complex mTBI symptoms.

Participant Groups

Group I: T-MD Intervention Group Experimental Treatment 1 Intervention

Participants will be prescribed 1+ interventions tailored to affected domains.Anxiety/Mood-Cog beh therapy(CBT) for maladaptive beliefs/avoidance/coping behaviors. Graded exposure/activity/relaxation exercises, cognitive restructuring. Cognitive-Accommodations for reduced work/school time/delayed deadlines, more frequent/longer cognitive rest during symptom-provoking activities. Migraine/Headache: Education, relaxation training/mindfulness based therapy. Ocular-Exercises for ocular symptoms, near point convergence, may include Brock string, pencil push-ups, fixation, saccade tracking, pursuits. Sleep-Sleep regulation/hygiene. Mindfulness-based training, morning physical activity, CBT.Vestibular-Exercises for dizziness, visual motion sensitivity, gait, imbalance that may include gaze stability, visual habituation, static and dynamic balance/gait.Autonomic-Graded aerobic exercise. Perform daily aerobic exercise, goal 80% HR max on a stationary bike/treadmill/walking/jogging.

Group II: Behavioral Management Active Control 1 Intervention

Participants in control group will receive standardized behavioral management strategies including: activity, hydration, nutrition, sleep, and stress management strategies. These strategies provide general methods to manage concussion symptoms and regulate daily activities to assist in the recovery of concussion. Clinicians will discuss and review a behavioral strategies handout with each participant and answer any questions they may have about the information in the handout. Contact time between clinicians and patients will be similar to avoid effects associated with more or less contact time.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Inova Health Care Services

Collaborator

Trials

80

Recruited

22,700+

Findings from Research

A pilot study involving 21 family physicians showed that training on new return-to-activity guidelines after concussion significantly increased physicians' knowledge (from 6.3 to 8.8 correct answers out of 10) and adherence to the guidelines (from 25% to 86%).

Despite the positive changes in knowledge and adherence, the study faced challenges in recruitment and retention, indicating that improvements are needed for a larger trial to effectively implement these guidelines in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. Silverberg, ND., Otamendi, T., Panenka, WJ., et al.[2023]

Psychoeducation and cognitive strategy instruction are effective treatment components for addressing prolonged concussion symptoms (PCS), particularly for cognitive impairments in attention, working memory, and executive functioning.

A personalized, dynamic approach to managing PCS, which includes individualized tracking of progress and treatment adaptation based on client performance, shows promise in effectively targeting functional goals disrupted by concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. Wright, J., Sohlberg, MM.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary care for patients with persistent symptoms following concussion: a systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary Concussion Management: A Model for Outpatient Concussion Management in the Acute and Post-Acute Settings. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Moving forward on the road to recovery after concussion: participant experiences of interdisciplinary intervention for persisting post-concussion symptoms. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Multi-domain assessment of sports-related and military concussion recovery: A scoping review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Characteristics of concussion subtypes from a multidomain assessment. [2022]