A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)Behavioral: Stretching and Toning (S/T)Behavioral: Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)
- Registration Number
- NCT06197685
- Lead Sponsor
- Kessler Foundation
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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
- Mild-to-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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cognitive Rehabilitation + Stretching and Toning The Kessler Foundation modified Story Memory Technique® (KF-mSMT®) 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. Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR) The Kessler Foundation modified Story Memory Technique® (KF-mSMT®) 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. Cognitive Rehabilitation + Stretching and Toning Stretching and Toning (S/T) 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. Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR) Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL) 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.
- Primary Outcome Measures
Name Time Method Change in objective new learning and memory (NLM). 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.
Change in everyday memory 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.
- Secondary Outcome Measures
Name Time Method Change in hippocampal volume 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.
Change in hippocampal function Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) 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.
Trial Locations
- Locations (1)
Kessler Foundation
🇺🇸East Hanover, New Jersey, United States