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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

CRUSH-IT Trial 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.Check my eligibility

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.See study design

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.

CRUSH-IT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in California Verbal Learning Test-3 Performance

Secondary outcome measures

Change in Everyday Memory Simulations Performance

Change in hippocampal activation

Change in hippocampal resting-state functional connectivity

+1 more

CRUSH-IT 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

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,678 Total Patients Enrolled

Nancy D Chiaravalloti, PhDPrincipal InvestigatorKessler Foundation

4 Previous Clinical Trials

261 Total Patients Enrolled

Media Library

KF-mSMT Plus Aerobic Exercise Training Clinical Trial Eligibility Overview. Trial Name: NCT05716048 — Phase 1

Traumatic Brain Injury Research Study Groups: KF-mSMT Plus Aerobic Exercise Training, KF-mSMT Plus Stretching Exercise Training

Traumatic Brain Injury Clinical Trial 2023: KF-mSMT Plus Aerobic Exercise Training Highlights & Side Effects. Trial Name: NCT05716048 — Phase 1

KF-mSMT Plus Aerobic Exercise Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05716048 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is KF-mSMT Plus Aerobic Exercise Training a safe and effective treatment for patients?

"Since the KF-mSMT Plus Aerobic Exercise Training is in its initial Phase 1 trial, meaning there are only minimal data collected on its safety and efficacy, it earned a score of 1 from our team at Power."

Answered by AI

Can new patients still join this scientific experiment?

"According to the information located on clinicaltrials.gov, this medical study is still recruiting participants. The trial was first announced on April 21st 2023 and recently updated on June 7th 2023."

Answered by AI

To which demographic is this clinical trial most suited?

"This trial is seeking roughly 60 participants who have been diagnosed with traumatic brain injury and fall between the ages of 18-65."

Answered by AI

Does this trial permit enrolment for participants younger than thirty years old?

"Eligible patients for this clinical trial must fall in the age bracket of 18-65. There are 157 trials conducted to assess treatments on individuals below the age of majority, and 752 studies dedicated to seniors aged 65+."

Answered by AI

What is the cap on participants in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this research experiment is still accepting participants as of June 7th 2023; the trial was initially posted on April 21st 2023. Sixty individuals need to be recruited from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury

Brian Sandroff 2023. "Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05716048.

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