NCT02032589

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

December 19, 2013

Last Update Submit

January 9, 2014

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological Assessment

    Baseline assessment, and Week 3

Secondary Outcomes (1)

  • Assessment of Global Functioning

    Baseline and Week 3

Study Arms (2)

Self-generation treatment

EXPERIMENTAL

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

Behavioral: Self-generation treatment

memory training

PLACEBO COMPARATOR

Treatment consists on traditional memory training

Interventions

Self-generation treatmentBEHAVIORAL

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

Self-generation treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Multiple sclerosis

You may not qualify if:

  • Diagnosis of other neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

  • 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.

    PMID: 28485659DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yael Goverover, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

  • John DeLuca, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Goverover, PhD

CONTACT

212-998-5854yg243@nyu.edu

Nancy B Moore, MA

CONTACT

973-324-8450nbmoore@kesslerfoundation.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Scientist

Study Record Dates

First Submitted

December 19, 2013

First Posted

January 10, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

US(1)