A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis (COMBINE)

Kessler Foundation

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: Stretching and Toning (S/T); Behavioral: Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL); Behavioral: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)

Study type: Interventional

Funder types: Other

Identifiers

NCT06197685

R123323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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
• 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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)

Experimental group

Description:

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.

Treatment:

Behavioral: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)

Behavioral: Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)

Cognitive Rehabilitation + Stretching and Toning

Experimental group

Description:

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.

Treatment:

Behavioral: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)

Behavioral: Stretching and Toning (S/T)