Clinical trial NCT03983681: Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
Official title: Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
Relapsing-Remitting MS
Progressive MS
RRMS
PPMS
SPMS
Primary Progressive
Secondary Progressive
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in scores on self-report measure of everyday cognition (subjective)
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
measure: Changes in scores on self-report measure of everyday cognition (objective)
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Secondary outcomes:
measure: Changes in auditory processing speed
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
measure: Changes in information processing speed
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
measure: Changes in episodic verbal memory and learning
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
measure: Changes in visuospatial memory
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
measure: Changes in ability in spontaneous production of words
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
measure: Changes in visual perception
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
measure: Changes in executive function
timeFrame: Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
city: Marlton
country: United States
facility: Kessler Rehabilitation Center
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Nancy D Chiaravalloti, PhD
role: PRINCIPAL_INVESTIGATOR
References: