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

Multiple Sclerosis Clinical Trial

— COMBINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197685
• Other study ID #: R123323
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Kessler Foundation
• Contact: Carly Wender, PhD
• Phone: (973) 324-8388
• Email: cwender[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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
• 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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in hippocampal volume	MRI data will be collected in the Rocco Ortenzio Neuroimaging Center at Kessler Foundation using an FDA-approved 3.0 T Siemens Skyra scanner and a 32-channel head coil to measure the volume of bilateral hippocampi.	Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
Secondary	Change in hippocampal function	fMRI data will be collected during a list-learning task conducted while in the FDA-approved 3.0 T Siemens Skyra scanner with a 32-channel head coil.	Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)