What side effects are associated with this type of intervention?

Remote rehabilitation programs for TBI, such as the TeleRehab program (ICARE), generally have minimal physical side effects since they focus on cognitive and emotional training rather than pharmacological interventions. However, patients may experience mental fatigue, frustration, or emotional distress as they engage in challenging cognitive tasks and emotional recognition exercises. Broader TBI treatments, including physical therapy and cognitive-behavioral therapy, can also lead to similar emotional and cognitive strain. It is important for patients to communicate with their healthcare providers to manage these side effects effectively.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs or treatments that directly mirror the TeleRehab program (ICARE) for remote rehabilitation aimed at improving emotional recognition and response in TBI patients. However, the FDA has approved various medications and therapies for managing symptoms associated with TBI, such as cognitive enhancers, antidepressants, and medications for managing pain and spasticity. Additionally, rehabilitation programs, including physical, occupational, and speech therapy, are commonly used to support recovery in TBI patients.

What other types of research exist?

Promising novel alternatives to the TeleRehab program (ICARE) for TBI patients in 2024 include: 1) Virtual Reality (VR) therapy, which uses immersive environments to enhance emotional recognition and response; 2) Mobile health applications that provide personalized cognitive and emotional rehabilitation exercises; 3) Remote patient monitoring systems that track emotional and cognitive metrics in real-time; and 4) AI-driven telehealth platforms that offer tailored therapeutic interventions based on patient data.

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ICARE Treatment for Traumatic Brain Injury (ICARE Trial)

N/A

Recruiting

Led By Flora Hammond, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-test 1), week 7, week 14, week 26, week 38

Awards & highlights

Summary

This trial tests a remote rehab program called ICARE to help people with brain injuries and their caregivers improve emotional understanding and relationships. It aims to teach them how to better recognize and respond to emotions, enhancing their relationship quality and emotional well-being.

Who is the study for?

This trial is for U.S. residents over 18 years old who are at least one year post-traumatic brain injury (TBI) and have difficulties with emotion recognition or empathy that they believe started after TBI. Participants must speak English, be able to follow directions, and have a care partner willing to join the study. They need internet access for video calls but can't be from California or have other neurological conditions affecting emotions.

What is being tested?

The ICARE Treatment program is being tested in this trial. It's a TeleRehab intervention designed to help people with TBI improve their ability to recognize and respond to others' emotions using video conferencing technology alongside their care partners.

What are the potential side effects?

Since ICARE Treatment involves therapy sessions rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or fatigue during the exercises aimed at improving affect recognition and empathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-test 1), week 7, week 14, week 26, week 38

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-test 1), week 7, week 14, week 26, week 38

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-test 1), week 7, week 14, week 26, week 38 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 St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB)

Secondary study objectives

Change in Advanced Clinical Solutions- Social Perception- Facial Affect Naming subscale (ACS-SP-FAN)

Change in Brock Adaptive Functioning Questionnaire, empathy subscale (BAFQ-E)

Change in Daily Empathic Behavior Survey (DEBS)

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ICARE)Experimental Treatment1 Intervention

ICARE treatment consisting of 12 sessions that train affect recognition and empathic behaviors.

Do I qualify?Apply below to find out

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

The most common treatments for Traumatic Brain Injury (TBI) include cognitive-behavioral therapy (CBT), physical therapy, and remote rehabilitation programs like TeleRehab (ICARE). These treatments work by targeting different aspects of brain function and recovery. CBT helps patients by restructuring negative thought patterns and improving emotional regulation, which is crucial for managing the psychological impact of TBI. Physical therapy focuses on restoring motor function and coordination through repetitive exercises that promote neuroplasticity. Remote rehabilitation programs, such as TeleRehab, leverage technology to provide consistent, accessible therapy aimed at improving cognitive functions like emotional recognition and response. These mechanisms are vital for TBI patients as they address both the physical and emotional challenges of recovery, ultimately enhancing their quality of life and functional independence.

The effectiveness of traumatic brain injury rehabilitation: a review.Delivering group treatment via videoconference to individuals with traumatic brain injury: a feasibility study.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

1,019 Previous Clinical Trials

1,114,135 Total Patients Enrolled

Flora Hammond, MDPrincipal InvestigatorIndiana University

5 Previous Clinical Trials

329 Total Patients Enrolled

Dawn Neumann, Ph.D.Principal InvestigatorIndiana University

Media Library

ICARE Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05636020 — N/A

Traumatic Brain Injury Research Study Groups: Treatment (ICARE)

Traumatic Brain Injury Clinical Trial 2023: ICARE Treatment Highlights & Side Effects. Trial Name: NCT05636020 — N/A

ICARE Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05636020 — N/A

~52 spots leftby Aug 2027

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