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Testing the Efficacy of Self-Generation Treatment Protocol

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-generation treatment
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Multiple sclerosis

Exclusion Criteria:

  • Diagnosis of other neurological conditions

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Self-generation treatment

memory training

Arm Description

self-generation strategy treatment, embedded within practice of various activities

Treatment consists on traditional memory training

Outcomes

Primary Outcome Measures

Neuropsychological Assessment

Secondary Outcome Measures

Assessment of Global Functioning

Full Information

First Posted
December 19, 2013
Last Updated
January 9, 2014
Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT02032589
Brief Title
Testing the Efficacy of Self-Generation Treatment Protocol
Official Title
Exploring the Effects of a Memory Intervention on Memory and Everyday Life Activities With Persons With MS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
National Multiple Sclerosis Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Past research has shown that items self-generated by an individual, such as words or concepts, are remembered better than items that are simply read or heard. The current study seeks to demonstrate the effectiveness of using the principles of the generation effect in a treatment intervention to improve memory and functional performance in individuals with Multiple Sclerosis who have learning and memory difficulties.The main purpose of the study is to conduct an experimental investigation on the effects of a self-generation strategy treatment, embedded within practice of various activities ranging from laboratory tasks (e.g. words and concepts) to functional tasks (e.g. activities of daily living). The treatment to be tested is geared toward helping patients selfdiscover their own strengths and abilities while using self-generation to be able to utilize it independently in everyday life situations. Design: The proposed pilot study is a randomized clinical trial. Participants: Participants will include forty (40) persons with MS, between the ages of 18 and 65, who demonstrate memory impairments. Half of the participants will receive the self-generation training while learning different types of tasks (experimental group) and half of the participants (control group) will be asked to learn the same information but will receive a conventional practice (e.g. repetitions). Expected results: We expect that participants undergoing the self-generation-training intervention will show better memory performance, functional performance, quality of life, and satisfaction with treatment and life compared to participants in the control condition.
Detailed Description
If self- generation can be successfully adapted and applied to a treatment program for individuals with MS, it has the potential to improve their rehabilitation and treatment by facilitating new learning and memory. In addition, if treatment and rehabilitation are successful and productive, it is expected that the application of self-generation strategy to improve learning/ relearning will help to improve the ability of individuals with MS to maintain their current lifestyles at home, work, and within the community. We expect that persons with MS who complete the proposed treatment will acquire the trained strategy, recognize the everyday situations in which the trained strategy could be applied and then map and adapt the trained strategy to real-world situations. Fourty participants with clinically definite MS and objectively documented impairment in verbal new learning will be included in the study. Participants will be randomly assigned to either the treatment group (n=20) or the control group (n=20). Participants will be enrolled only following an informed consent procedure, with the expectation of being able to participate for the full duration of the study (6 treatment sessions and two assessment sessions). All participants enrolled in the study will undergo pre and post treatment assessment to assess their levels of cognitive, emotional, and functional performance. Treatment for both experimental and control groups will consist of 6 individualized treatment sessions, 2 x per week for 3 weeks. Each session will last for approximately 45 minutes, and will include various memory tasks that will range from learning list of words to learning tasks related to everyday life. Participants in the control group will only be asked to perform the same memory tasks as the treatment group. The treatment for the experimental group will couple self-generated learning with awareness-training techniques, which are geared toward helping patients self-discover their performance strengths and limitations through integration of direct and personal experiences. Personal experience will be gained by practicing various memory tasks using self-generation strategy. This proposed self-generation program is expected to increase memory, task specific awareness and functional performance; ultimately improving quality of life and self-regulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-generation treatment
Arm Type
Experimental
Arm Description
self-generation strategy treatment, embedded within practice of various activities
Arm Title
memory training
Arm Type
Placebo Comparator
Arm Description
Treatment consists on traditional memory training
Intervention Type
Behavioral
Intervention Name(s)
Self-generation treatment
Intervention Description
self-generation treatment is a cognitive rehabilitation strategy aimed to improve memory. The self-generation strategy treatment, embedded within practice of various activities will consists of six individualized intervention sessions administered over 2-3 weeks
Primary Outcome Measure Information:
Title
Neuropsychological Assessment
Time Frame
Baseline assessment, and Week 3
Secondary Outcome Measure Information:
Title
Assessment of Global Functioning
Time Frame
Baseline and Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Multiple sclerosis Exclusion Criteria: Diagnosis of other neurological conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yael Goverover, PhD
Phone
212-998-5854
Email
yg243@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy B Moore, MA
Phone
973-324-8450
Email
nbmoore@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Goverover, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John DeLuca, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy B Moore, MA
Phone
973-324-8450
Email
nbmoore@kesslerfoundation.org
First Name & Middle Initial & Last Name & Degree
John DeLuca, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28485659
Citation
Goverover Y, Chiaravalloti N, Genova H, DeLuca J. A randomized controlled trial to treat impaired learning and memory in multiple sclerosis: The self-GEN trial. Mult Scler. 2018 Jul;24(8):1096-1104. doi: 10.1177/1352458517709955. Epub 2017 May 9.
Results Reference
derived

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Testing the Efficacy of Self-Generation Treatment Protocol

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