Treating New Learning and Memory Deficits in Progressive Multiple Sclerosis (MS)

NCT02301247 | Completed

• 1 other identifier: R-839-14
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-blind placebo-controlled randomized clinical trial (RCT) to provide Class I evidence in support of or in refute of the efficacy of the modified Story Memory Technique (mSMT) in persons with progressive MS, with outcome measured through three mechanisms: (1) a traditional neuropsychological evaluation (NPE) (2) an assessment of global functioning (AGF) examining the impact of the treatment on daily activities, and (3) an optional functional magnetic resonance imaging (fMRI) scan.

Conditions

Multiple Sclerosis, Progressive; Cognition - Other; Memory Impairment

Keywords

Multiple Sclerosis, Progressive; cognition; memory; treatment

Outcome Measures

Primary Outcomes (1)

• Change in scores on standardized neuropsychological tests of memory

  Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

Secondary Outcomes (3)

• Change in scores on self-report of emotional functioning, measured via questionnaire

  Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

• Change in scores on self-report of memory functioning, measured via questionnaire

  Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

• Change in scores on self-report of quality of life, measured via questionnaire

  Scores will be assessed at three time-points: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will receive memory retraining exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Behavioral: Memory retraining exercises

Placebo

PLACEBO COMPARATOR

The placebo group will receive placebo control memory exercises administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Behavioral: Placebo control memory exercises

Interventions

Memory retraining exercises BEHAVIORAL

Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Experimental Group

Placebo control memory exercises BEHAVIORAL

Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).

Placebo

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• between the ages of 30 and 59
• diagnosed with Progressive Multiple Sclerosis
• have visual acuity of better then 20/60 in worse eye

You may not qualify if:

• has a prior stroke or neurological injury/disease (brain tumor, epilepsy, traumatic brain injury).
• has a history of psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).
• currently taking medications such as: steroids, benzodiazepines, and neuroleptics. .
• difficulty with vision, eyesight worse then 20/60, or has diminished sight in visual field, double vision, or nystagmus.

Sponsors & Collaborators

• Kessler Foundation: lead
• International Progressive MS Alliance: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Memory Disorders

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Matthew R Weiner

  Kessler Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neuroscience and Neuropsychology Research

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: April 2, 2017
• Study Completion: April 2, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (1)