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

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT06197685
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 12, 2024
Status verified
Mar 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)
    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.
  • Experimental: Cognitive Rehabilitation + Stretching and Toning
    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.

Primary Outcome Measure

Change in objective new learning and memory (NLM). [ Time Frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationEast HanoverNew Jersey07936
Carly Wender, PhD
[email protected]
9732436984

Find similar trials in East Hanover, NJ

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Kessler Foundation· East Hanover, NJ

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