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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR) | Experimental | 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. |
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| Cognitive Rehabilitation + Stretching and Toning | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Kessler Foundation modified Story Memory Technique® (KF-mSMT®) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in objective new learning and memory (NLM). | 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) |
| Change in everyday memory | 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. | Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hippocampal volume | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carly Wender, PhD | Contact | (973) 324-8388 | cwender@kesslerfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Carly Wender, PhD | Kessler Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | East Hanover | New Jersey | 07936 | United States |
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Participants will be blinded to the intent of the two exercise conditions. The outcomes assessor will also be blinded to the random assignment of enrolled participants.
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| Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL) | Behavioral | 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. |
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| Stretching and Toning (S/T) | Behavioral | 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. |
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| Change in hippocampal function |
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. |
| Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000338 | beta-Aminoethyl Isothiourea |
| ID | Term |
|---|---|
| D013890 | Thiourea |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
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