RecruitingNot ApplicableNCT06197685

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


Sponsor

Kessler Foundation

Enrollment

78 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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)

Interventions

BEHAVIORALThe Kessler Foundation modified Story Memory Technique® (KF-mSMT®)

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.

BEHAVIORALAerobic Exercise Training (AET) plus Virtual Reality (IDEAL)

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.

BEHAVIORALStretching and Toning (S/T)

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.


Locations(1)

Kessler Foundation

East Hanover, New Jersey, United States

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NCT06197685


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