Targeted Multidomain Intervention for Concussion

(T-MD Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a specialized treatment plan for individuals with mild traumatic brain injury (mTBI), focusing on issues such as anxiety, headaches, and dizziness, compared to regular care. Participants will be divided into groups: one group will receive a targeted intervention with therapies tailored to their symptoms (behavioral management), while the other group will receive standard advice on managing concussion symptoms. Individuals who have experienced a complex mTBI in the last 8 days to 6 months and are dealing with issues like mood changes or headaches may be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance future treatment options for 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that targeted multidomain interventions (T-MD) for complex mild traumatic brain injury (mTBI) are generally well-tolerated. Studies have tracked participants to ensure these treatments are safe and effective, monitoring their progress over time.

The T-MD approach includes various therapies for symptoms such as anxiety, migraines, and sleep problems. These treatments are primarily behavioral and involve activities like cognitive therapy (talk therapy to help with thinking patterns), relaxation exercises, and physical activity.

Since these interventions are non-invasive and involve therapy and exercises, they usually carry a low risk of serious side effects. However, as with any treatment, some individuals might experience mild discomfort or side effects from increased activity or new routines.

Overall, past research suggests these interventions are safe, especially since they use common therapeutic practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the targeted multidomain intervention for concussion because it offers a comprehensive, personalized approach that goes beyond standard treatments like rest and gradual return to activity. This innovative method tailors interventions to specific symptoms, such as anxiety, cognitive challenges, migraines, and balance issues, incorporating techniques like cognitive-behavioral therapy, graded aerobic exercise, and mindfulness. By addressing multiple domains simultaneously, this approach aims to accelerate recovery and improve overall outcomes, which could revolutionize how concussions are managed.

What evidence suggests that this trial's treatments could be effective for concussion?

Research has shown that targeted multidomain (T-MD) treatments, which participants in this trial may receive, can assist individuals with complex mild traumatic brain injury (mTBI) by addressing multiple issues simultaneously. These issues include mood and anxiety, thinking and memory, headaches, eye coordination, sleep, balance, and overall fitness. Early results suggest these treatments can enhance daily life and alleviate symptoms. Different methods, such as cognitive behavioral therapy (a type of talk therapy) and specific exercises, are tailored to each individual. Although the T-MD approach remains under investigation, early evidence is promising for managing the complex symptoms of mTBI. Meanwhile, participants in the Behavioral Management arm will receive standardized strategies to manage concussion symptoms, focusing on activity, hydration, nutrition, sleep, and stress management. ^{1 2 3 5 6}

Who Is on the Research Team?

Anthony P Kontod, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10349652/

Targeted multidomain intervention for complex mTBI This multisite randomized controlled trial (RCT) will determine the effectiveness of a targeted multidomain (T-MD) intervention (anxiety/mood, cognitive, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04549532

Targeted Multidomain (T-MD) Interventions for Complex ... Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37456641/

Targeted multidomain intervention for complex mTBI This multisite randomized controlled trial (RCT) will determine the effectiveness of a targeted multidomain (T-MD) intervention (anxiety/mood, cognitive, ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04549532/targeted-multidomain-t-md-interventions-for-complex-mild-traumatic-brain-injury-mtbi

Targeted Multidomain (T-MD) Interventions for Complex ... Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, ...

5. withpower.com withpower.com/trial/phase-brain-injuries-5-2021-88a95

Targeted Multidomain Intervention for Concussion (T-MD ... Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04549532?keyword=%22mTBI%22

Targeted Multidomain (T-MD) Interventions for Complex ... Primary outcomes for Aim 1 will be assessed at baseline, 2-week, 4-week, and 3-month post-intervention intervals. Secondary outcomes for Aim 1 will be assessed ...