Evaluation of a Theory-Driven Manualized Approach to Improving New Learning and Memory in MS (STEM)

Kessler Foundation

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Behavioral: Strategy-Based Training to Enhance Memory (STEM); Behavioral: Placebo control exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT03983681

R-1045-18

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

The experimental group will receive memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

Treatment:

Behavioral: Strategy-Based Training to Enhance Memory (STEM)

Control group

Placebo Comparator group

Description:

The control group will receive placebo memory enhancement exercises administered twice a week for 4 weeks (8 training sessions).

Treatment:

Behavioral: Placebo control exercises