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

Memory Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301247
• Other study ID #: R-839-14
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: June 30, 2017
• Start date: November 2014
• Est. completion date: April 2, 2017

Study information

• Verified date: June 2017
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

There is a clear unmet need in the clinical care of persons with Progressive MS - there are no treatments for memory dysfunction with demonstrated efficacy in persons with progressive disease. This is despite the fact that cognitive impairment is a major contributor to unemployment and decreased functional status in MS and memory deficits are a major source of such disability. The investigator recent RCT's demonstrated the modified Story Memory Technique (mSMT) to be effective for improving new learning and memory in individuals with MS, demonstrating efficacy across three realms of functioning, objective behavior, brain functioning and everyday life. This convincing data provides Class I evidence supporting the efficacy of the mSMT for improving new learning and memory in MS. However, treatment efficacy was not adequately tested in the progressive MS population. This is a major limitation due to the fact that progressive MS carries with it major cognitive difficulties, of which learning and memory are one of the most common. The currently proposed RCT will address this limitation. The investigators will use methodologically vigorous research design to provide Class I evidence in support of or in refute of the efficacy of the 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. Both groups will undergo baseline, immediate follow-up, and 3-month follow-up assessments

Thus, the current study will objectively evaluate the clinical utility of the mSMT to improve new learning and memory in individuals with progressive MS with documented deficits in this area. This protocol has been previously utilized in a Relapsing-Remitting MS sample, yielding exceptional outcome data. Pilot data in a small sample of progressive MS patients is promising. The investigators will also increase the generalizability and real life application of assessment techniques by assessing outcome following cognitive retraining with more global measures of everyday life. Finally, the long-term efficacy of the mSMT will be evaluated in progressive MS through the inclusion of a 3-month follow-up assessment. Given the absence of any treatment for impaired learning and memory in progressive patients, the results of the present RCT will have a significant impact on symptom management and quality of life for persons with Progressive MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2, 2017
• Est. primary completion date: April 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

Inclusion Criteria:

• between the ages of 30 and 59

• diagnosed with Progressive Multiple Sclerosis

• have visual acuity of better then 20/60 in worse eye

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cognition - Other
• Memory Disorders
• Memory Impairment
• Multiple Sclerosis
• Multiple Sclerosis, Progressive
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	International Progressive MS Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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