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NCT05716048 · ClinicalTrials.gov registry record · Phase 1
Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury
A Phase 1 study of Traumatic Brain Injury, sponsored by Kessler Foundation.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05716048 is a Phase 1 study of Traumatic Brain Injury that is actively recruiting participants, run by Kessler Foundation. The registered enrollment target is 60 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05716048, a Phase 1 study of Traumatic Brain Injury, is actively recruiting participants, sponsored by Kessler Foundation.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
New learning and memory impairment (NLMI) is a common and devastating manifestation of TBI associated with substantial life burdens. Persons with moderate to severe TBI have shown improvement in NLM for prose material (e.g. story) as well as beneficial changes in default-mode network (DMN) activation during list-learning19 following treatment with the Kessler Foundation modified Story Memory Technique® (KF-mSMT®). Benefits, however, were moderate and did not yield downstream improvements in daily life. It is thus critical to examine other approaches to complement the KF-mSMT® for robustly managing NLMI in TBI. The proposed RCT will be the first to include aerobic exercise training (AET) as a highly-promising complement to the KF-mSMT® for robustly managing NLMI, examining impact on NLM, its neural correlates, and daily life in NLM impaired persons with moderate-to-severe TBI. We thus propose a two-arm, parallel group, double-blind RCT comparing the effects of the KF-mSMT+AET with the KF-mSMT+S/T (active control condition) on NLM (Aim 1), hippocampal MRI (Aim 2), and daily life outcomes (Aim 3). 60 NLM impaired persons with moderate-to-severe TBI will be randomized to one of 2 conditions (30 per condition). Each condition will take place 3 days per week for 12 weeks and will be supervised by KF personnel. Participants will be blinded as to the intent of the conditions. We will further explore baseline predictors of clinically meaningful changes in NLM for those completing the KF-mSMT + AET condition (Exploratory Aim 4). If successful, this trial will position combinatory KF-mSMT and AET within the clinician's arsenal for robustly managing NLMI in persons with TBI. By augmenting the effects of KF-mSMT with AET, this treatment aims to exert a powerful countermeasure to TBI-related NLMI, and ultimately help those with TBI-related NLMI return to the workforce, independently manage their everyday lives, and maintain optimal quality of life. Additionally, while rigorously
Conditions Studied
Interventions
- BEHAVIORAL KF-mSMT Plus Aerobic Exercise Training
- BEHAVIORAL KF-mSMT Plus Stretching Exercise Training
Study Locations (1)
New Jersey
- Kessler Foundation - West Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-04-21 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05716048
The ClinicalTrials.gov registry entry for NCT05716048 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (78% lower). The listed sponsor is Kessler Foundation, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which KF-mSMT Plus Aerobic Exercise Training is the first listed.
NCT05716048 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT05716048 about?
NCT05716048 is a clinical study titled "Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury". New learning and memory impairment (NLMI) is a common and devastating manifestation of TBI associated with substantial life burdens. Persons with moderate to severe TBI have shown improvement in NLM for prose material (e.g. story) as well as beneficial changes in default-mode network (DMN) activatio...
What is the current status of trial NCT05716048?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-04-21. Estimated completion is 2028-02-28.
What conditions does trial NCT05716048 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT05716048?
The interventions under investigation include: KF-mSMT Plus Aerobic Exercise Training (BEHAVIORAL), KF-mSMT Plus Stretching Exercise Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT05716048?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05716048 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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