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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in objective new learning and memory (NLM). [Срок оценки: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]
• Change in everyday memory [Срок оценки: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]

Вторичные конечные точки (2)

• Change in hippocampal volume [Срок оценки: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]
• Change in hippocampal function [Срок оценки: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kessler Foundation — East Hanover

Идентификаторы

NCT: NCT06197685 · R123323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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