Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2025-09-30

Brief Summary

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The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis.

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Detailed Description

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The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with Multiple Sclerosis (MS). The study is designed to research how well this technique can help people with MS improve their memory and their ability to function better in everyday life.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Participants will be blind as to which treatment group they are being placed. Study staff conducting baseline and follow-up assessments will also be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance.

Study Groups

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Experimental

The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

Group Type EXPERIMENTAL

Strategy-Based Training to Enhance Memory (STEM)

Intervention Type BEHAVIORAL

Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).

Control group

The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

Group Type PLACEBO_COMPARATOR

Placebo control exercises

Intervention Type BEHAVIORAL

Placebo control memory exercises will be administered for 4 weeks (8 training sessions).

Interventions

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Strategy-Based Training to Enhance Memory (STEM)

Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).

Intervention Type BEHAVIORAL

Placebo control exercises

Placebo control memory exercises will be administered for 4 weeks (8 training sessions).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Multiple Sclerosis
* Ability to read and speak English fluently
* Difficulties with learning and memory skills

Exclusion Criteria

* Prior diagnosis of stroke or other neurological injury/disease
* Flare up of symptoms within a month of study participation
* History of significant psychiatric illness (e.g., bipolar disorder, schizophrenia, psychosis) or current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II
* Current significant alcohol or substance abuse
* Taking exclusionary medication (study team will review medications)

For Optional MRI:

* Pacemaker or other implanted electrical device, brain stimulator, aneurysm clip (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
* Dental implants
* Left-handed

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No