NCT06197685

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
2mo left

Started Feb 2024

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Feb 2024Jun 2026

First Submitted

Initial submission to the registry

December 4, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

September 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

December 4, 2023

Last Update Submit

August 25, 2025

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisAerobic exerciseVirtual RealityLeg cyclingMobility disability

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (2)

  • Change in hippocampal volume

    Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)

  • Change in hippocampal function

    Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)

Study Arms (2)

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.

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

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.

Behavioral: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)Behavioral: Stretching and Toning (S/T)

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.

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

Also known as: IDEAL
Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)
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.

Cognitive Rehabilitation + Stretching and Toning

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

beta-Aminoethyl Isothiourea

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThioureaUreaAmidesOrganic ChemicalsSulfur Compounds

Study Officials

  • Carly Wender, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Wender, PhD

CONTACT

(973) 324-8388cwender@kesslerfoundation.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

December 4, 2023

First Posted

January 9, 2024

Study Start

February 12, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

September 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)