Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, MS, Relapsing-Remitting MS, Progressive MS, RRMS, PPMS, SPMS, Primary Progressive, Secondary Progressive
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.
Interventions
BEHAVIORALStrategy-Based Training to Enhance Memory (STEM)
Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).
BEHAVIORALPlacebo control exercises
Placebo control memory exercises will be administered for 4 weeks (8 training sessions).
Sponsors
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants will be blind as to which treatment group they are being placed. Study staff conducting baseline and follow-up assessments will also be blind as to which group participants are placed. Study staff conducting intervention sessions will be blind to participants' baseline and follow-up assessment performance.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in scores on self-report measure of everyday cognition (subjective) | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Perceived Deficits Questionnaire |
| Changes in scores on self-report measure of everyday cognition (objective) | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Ecologic Memory Simulations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in auditory processing speed | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Paced Auditory Serial Edition Test |
| Changes in information processing speed | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Symbol Digit Modalities Test |
| Changes in episodic verbal memory and learning | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | California Verbal Learning Test - 2nd Edition |
| Changes in visuospatial memory | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Brief Visuospatial Memory Test - Revised |
| Changes in ability in spontaneous production of words | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Controlled Oral Word Association Test |
| Changes in visual perception | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Benton Judgment of Line Orientation |
| Changes in executive function | Baseline (week 1), immediately post-intervention (week 6) and long-term follow-up (week 6 months post-intervention) | Delis-Kaplan Executive Function System - Sorting |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy D Chiaravalloti, PhD
Kessler Foundation
Outcome results
None listed