Clinical trial NCT06197685: A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis
Official title: A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Aerobic exercise
Virtual Reality
Leg cycling
Mobility disability
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2024-01-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in objective new learning and memory (NLM).
timeFrame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
measure: Change in everyday memory
timeFrame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
Secondary outcomes:
measure: Change in hippocampal volume
timeFrame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
measure: Change in hippocampal function
timeFrame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Carly Wender, PhD
role: PRINCIPAL_INVESTIGATOR
References: