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Combinatory Rehabilitation for Traumatic Brain Injury (CRUSH-IT Trial)

Phase 1

Recruiting

Led By Nancy D Chiaravalloti, PhD

Research Sponsored by Kessler Foundation

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 from 0 to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to provide evidence of combined KF-mSMT and AET for rehabilitating NLMI in TBI, to help those with TBI-related NLMI return to work, manage everyday life and maintain quality of life.

Who is the study for?

This trial is for adults aged 18-65 with moderate-to-severe traumatic brain injury (TBI) diagnosed at least a year ago. Participants should be physically inactive, right-handed, have memory impairments, and able to follow directions. They must not have severe mental illness, regular steroid or benzodiazepine use, significant vision impairment, unsafe conditions for MRI scans or high exercise risks.

What is being tested?

The study tests the Kessler Foundation modified Story Memory Technique (KF-mSMT) combined with either aerobic exercise training (AET) or stretching exercises. It's a double-blind randomized controlled trial aiming to improve new learning and memory in TBI patients by comparing these two methods over a 12-week program.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to physical activity such as muscle soreness or fatigue from aerobic or stretching exercises. Since it's an exercise-based intervention, risks might also involve strain injuries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 0 to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 0 to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 12 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 California Verbal Learning Test-3 Performance

Secondary study objectives

Change in Everyday Memory Simulations Performance

Change in hippocampal activation

Change in hippocampal resting-state functional connectivity

+1 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

Active Control

Group I: KF-mSMT Plus Aerobic Exercise TrainingExperimental Treatment1 Intervention

Participants will undergo 12 weeks of supervised aerobic cycling exercise training. During the last 8 weeks of cycling exercise, participants will also undergo treatment with the Kessler Foundation modified Story Memory Technique as an approach for cognitive rehabilitation.

Group II: KF-mSMT Plus Stretching Exercise TrainingActive Control1 Intervention

Participants will undergo 12 weeks of supervised stretching and toning exercise training. During the last 8 weeks of stretching exercise, participants will also undergo treatment with the Kessler Foundation modified Story Memory Technique as an approach for cognitive rehabilitation.

Do I qualify?Apply below to find out