- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197685
A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis (COMBINE)
March 15, 2024 updated by: Kessler Foundation
The goal of this novel study is to compare the effect of a combined cognitive rehabilitation and exercise approach on new learning and memory (NLM) in persons with multiple sclerosis (pwMS) and mobility disability.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The proposed research study will be the first to apply the Kessler Foundation modified Story Memory Technique (KF-mSMT®), the practice standard for cognitive rehabilitation, with one of two exercise programs.
Alone, KF-mSMT® has been beneficial to NLM impairment, however, its effects are highly selective to list learning and as such, will not maximally restore NLM function.
The combination of KF-mSMT® and exercise provides a robust approach towards maximal functional recovery.
Study Type
Interventional
Enrollment (Estimated)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carly Wender, PhD
- Phone Number: (973) 324-8388
- Email: cwender@kesslerfoundation.org
Study Locations
-
-
New Jersey
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East Hanover, New Jersey, United States, 07936
- Recruiting
- Kessler Foundation
-
Contact:
- Carly Wender, PhD
- Phone Number: 973-243-6984
- Email: cwender@kesslerfoundation.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be within the ages of 18 and 70 years of age
- Speak English as their primary language
- Confirmed MS diagnosis by a neurologist
- Be relapse and steroid-free for at least 30 days
- Moderate self-reported mobility disability, based on the Patient Determined Disease Steps scale (PDDS)
- Currently physically inactive, based on the Godin Leisure Time Exercise Questionnaire (GLTEQ)
- Right handedness
Exclusion Criteria:
- History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)
- Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)
- Currently use medications that may impact cognition (ex: steroids, benzodiazepines)
- Currently pregnant
- Contraindication for MRI (metal or electronic devices in the body that are not considered MRI safe)
- Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)
In the cognitive rehabilitation and aerobic exercise with VR condition, participants will complete a supervised, aerobic exercise training program (AET) integrated with virtual reality (Ideally Designed Exercise to Accelerate Learning/memory; IDEAL) three days per week over a 12 week period.
For seven weeks, participants will only complete IDEAL.
For weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
|
KF-mSMT is a memory retraining technique that consists of two-related skills: (1) imagery and (2) context/organization.
The proposed KF-mSMT intervention includes 10 total sessions with 2 sessions per week for 5 weeks.
Each session will last 45-60 minutes.
The AET condition includes 12 weeks of supervised, progressive, moderate intensity cycle ergometry.
The AET will include semi-immersive, interactive VR such the cycling speed on the bike will translate directly to perceived speed through the virtual environment.
Other Names:
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Experimental: Cognitive Rehabilitation + Stretching and Toning
In the cognitive rehabilitation and stretching and toning (S/T) exercise condition, participants will complete 12 weeks of supervised S/T activities 3 days per week over the 12 week period.
For seven weeks, participants will only complete S/T.
During weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
|
KF-mSMT is a memory retraining technique that consists of two-related skills: (1) imagery and (2) context/organization.
The proposed KF-mSMT intervention includes 10 total sessions with 2 sessions per week for 5 weeks.
Each session will last 45-60 minutes.
The S/T condition will include 12 weeks of supervised S/T activities that target the head/neck.
shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in objective new learning and memory (NLM).
Time Frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
|
The California Verbal Learning Test-Second Edition (CVLT-II) measures verbal learning and memory by having participants recall a list of words from 4 semantic categories.
The word list is presented over 5 trials with a 20 minute delayed recall and recognition trial.
Standardized T-scores range from 0-100, where higher scores indicated better performance.
|
Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
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Change in everyday memory
Time Frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
|
The Ecological Memory Simulations (EMS) is a multi-component test that measures memory as it relates to everyday life.
Scores range from 0-205, where higher scores indicated better performance.
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Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in hippocampal volume
Time Frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
|
MRI data will be collected in the Rocco Ortenzio Neuroimaging Center at Kessler Foundation using an FDA-approved 3.0 T Siemens Skyra scanner and a 32-channel head coil to measure the volume of bilateral hippocampi.
|
Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
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Change in hippocampal function
Time Frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
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fMRI data will be collected during a list-learning task conducted while in the FDA-approved 3.0 T Siemens Skyra scanner with a 32-channel head coil.
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Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carly Wender, PhD, Kessler Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Study Registration Dates
First Submitted
December 4, 2023
First Submitted That Met QC Criteria
December 26, 2023
First Posted (Actual)
January 9, 2024
Study Record Updates
Last Update Posted (Actual)
March 18, 2024
Last Update Submitted That Met QC Criteria
March 15, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R123323
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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