A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis
NCT ID: NCT06197685
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
78 participants
INTERVENTIONAL
2024-02-12
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Combinatory Rehabilitation Used for Substantially Helping Individuals With Traumatic Brain Injury
NCT05716048
Improving Cognition in People With Progressive Multiple Sclerosis Using Aerobic Exercise and Cognitive Rehabilitation
NCT03679468
Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT
NCT03677440
Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
NCT03983681
The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS
NCT04075968
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
The 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.
Aerobic 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.
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.
The 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.
Stretching 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The 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.
Aerobic 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.
Stretching 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Multiple Sclerosis Society
OTHER
Kessler Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carly Wender
Research Scientist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carly Wender, PhD
Role: PRINCIPAL_INVESTIGATOR
Kessler Foundation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kessler Foundation
East Hanover, New Jersey, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R123323
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.