NCT02081508

Brief Summary

The purpose of this research study is to investigate whether minimizing interference improves memory in multiple sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

March 5, 2014

Last Update Submit

July 28, 2016

Conditions

Multiple Sclerosis

Keywords

Memory

Outcome Measures

Primary Outcomes (1)

  • Recall Proportion

    2 hours

Study Arms (4)

Unfilled interference

EXPERIMENTAL

Interference onset: delayed test at 540000 ms

Behavioral: Interference onset

Early interference

EXPERIMENTAL

Interference onset: delayed test at 0 ms

Behavioral: Interference onset

Mid interference

EXPERIMENTAL

Interference onset: delayed test at 360000 ms

Behavioral: Interference onset

Late interference

EXPERIMENTAL

Interference onset: delayed test at 180000 ms

Behavioral: Interference onset

Interventions

Interference onsetBEHAVIORAL

Temporal duration of interference onset.

Early interferenceLate interferenceMid interferenceUnfilled interference

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Scientist Neuropsychology & Neuroscience Research

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

US(1)