Back to resultsConsolidation & Interference in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interference onset
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Memory
Eligibility Criteria
Inclusion Criteria:
- If you are between the ages of 18-65.
- If you have a diagnosis of Multiple Sclerosis (MS) or are medically healthy.
- If you have MS, you have not had a flare up of MS symptoms in the past month.
- You do not have other neurological issues such as, Epilepsy or Stroke.
- You do not have a significant history of psychiatric problems or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder .
- You do not have a significant history of drug or alcohol abuse.
- You can read and speak English fluently.
- You are not currently taking steroids.
Exclusion Criteria:
- You are younger than 18 years old.
- You are older than 65 years old.
- You have had a prior stroke or neurological disease other than MS.
- You have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Bipolar Disorder.
- You have a significant alcohol or drug abuse history.
- You are currently taking steroids.
Sites / Locations
- Kessler Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Unfilled interference
Early interference
Mid interference
Late interference
Arm Description
Interference onset: delayed test at 540000 ms
Interference onset: delayed test at 0 ms
Interference onset: delayed test at 360000 ms
Interference onset: delayed test at 180000 ms
Outcomes
Primary Outcome Measures
Recall Proportion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02081508
Brief Title
Consolidation & Interference in Multiple Sclerosis
Official Title
Consolidation & Interference in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to investigate whether minimizing interference improves memory in multiple sclerosis.
Detailed Description
The ability to form new long-lasting memories is important for successful independent living and a high quality of life. Roughly half of the individuals diagnosed with Multiple Sclerosis (MS) have difficulty remembering new information and this is likely associated with poor acquisition of new information. There are only a limited number of studies that have investigated memory consolidation in MS. The current study will investigate the role of interference during the consolidation time period of memory formation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unfilled interference
Arm Type
Experimental
Arm Description
Interference onset: delayed test at 540000 ms
Arm Title
Early interference
Arm Type
Experimental
Arm Description
Interference onset: delayed test at 0 ms
Arm Title
Mid interference
Arm Type
Experimental
Arm Description
Interference onset: delayed test at 360000 ms
Arm Title
Late interference
Arm Type
Experimental
Arm Description
Interference onset: delayed test at 180000 ms
Intervention Type
Behavioral
Intervention Name(s)
Interference onset
Intervention Description
Temporal duration of interference onset.
Primary Outcome Measure Information:
Title
Recall Proportion
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
If you are between the ages of 18-65.
If you have a diagnosis of Multiple Sclerosis (MS) or are medically healthy.
If you have MS, you have not had a flare up of MS symptoms in the past month.
You do not have other neurological issues such as, Epilepsy or Stroke.
You do not have a significant history of psychiatric problems or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder .
You do not have a significant history of drug or alcohol abuse.
You can read and speak English fluently.
You are not currently taking steroids.
Exclusion Criteria:
You are younger than 18 years old.
You are older than 65 years old.
You have had a prior stroke or neurological disease other than MS.
You have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Bipolar Disorder.
You have a significant alcohol or drug abuse history.
You are currently taking steroids.
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Consolidation & Interference in Multiple Sclerosis
We'll reach out to this number within 24 hrs