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Behavioural Intervention

Active tDCS for Early Multiple Sclerosis

N/A
Recruiting
Led By Leigh Charvet, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (visit 1)
Awards & highlights

Study Summary

This trial looked at whether a measure of cognitive functioning called intra-individual variability, derived from a computer-based continuous reaction time task, could be used as an early marker of prodromal MS.

Who is the study for?
This trial is for adults aged 23-59 who may be in the early stages of Multiple Sclerosis (MS), specifically with a recent first MRI or clinical event. Participants should not have severe skin conditions, claustrophobia, cognitive impairments, psychiatric disorders that affect participation, uncontrolled seizures, pregnancy/breastfeeding status, certain implants or piercings that interfere with MRI scans.Check my eligibility
What is being tested?
The study tests whether variations in reaction times on a computer task can indicate early MS. It uses active transcranial direct current stimulation (tDCS) to assess cognitive markers in individuals showing initial signs of MS without yet having a definitive diagnosis.See study design
What are the potential side effects?
While the description does not specify side effects for tDCS, common ones include mild tingling or itching under electrode sites during stimulation and slight fatigue or headache post-treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (visit 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (visit 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oxygen
Intra-Individual Variability (IIV) as measured by Cogstate Brief Battery (CBB)
Secondary outcome measures
BICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Score
BICAMS Rey Auditory Verbal Learning Test (RAVLT) Score
Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Score
+1 more

Side effects data

From 2012 Phase 3 trial • 60 Patients • NCT01649232
10%
headache
10%
headedness / dizziness
7%
fatigue or nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active tDCS
Controls

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group with tDCS-MRIExperimental Treatment1 Intervention
Participants will have a cognitive assessment, an optional gait assessment, and a 1-hour MRI brain scan combined with 20 minutes of simultaneous tDCS. Participants may also complete the MRI on a separate visit.
Group II: Group without tDCS- MRIActive Control1 Intervention
Participants will have include a cognitive assessment and an optional gait assessment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active tDCS
2012
Completed Phase 3
~1150

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,538 Total Patients Enrolled
23 Trials studying Multiple Sclerosis
2,264 Patients Enrolled for Multiple Sclerosis
National Multiple Sclerosis SocietyOTHER
95 Previous Clinical Trials
9,423 Total Patients Enrolled
93 Trials studying Multiple Sclerosis
9,069 Patients Enrolled for Multiple Sclerosis
Leigh Charvet, MDPrincipal InvestigatorNYU Langone Health
7 Previous Clinical Trials
339 Total Patients Enrolled
6 Trials studying Multiple Sclerosis
318 Patients Enrolled for Multiple Sclerosis

Media Library

Computer-based continuous reaction time task (Cogstate) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05543915 — N/A
Multiple Sclerosis Research Study Groups: Group with tDCS-MRI, Group without tDCS- MRI
Multiple Sclerosis Clinical Trial 2023: Computer-based continuous reaction time task (Cogstate) Highlights & Side Effects. Trial Name: NCT05543915 — N/A
Computer-based continuous reaction time task (Cogstate) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543915 — N/A
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05543915 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment into this research study limited to those aged 85 years or younger?

"The age bracket for this trial is 23 to 59. However, there are alternatives available depending on the patient's age: 26 trials cater to those younger than 18 and 243 other studies target patients over 65."

Answered by AI

How many participants are involved in this experiment?

"Affirmative. According to the clinicaltrials.gov website, this trial is currently enrolling participants. It was originally posted on January 18th 2022 and last updated September 13th of that year. A total of 50 individuals are required from one medical facility for participation in the study."

Answered by AI

What are the anticipated results of this experiment?

"This study aims to measure Intra-Individual Variability (IIV) over the course of 4 minutes, evaluated with Cogstate Brief Battery (CBB). Secondary objectives include gauging a patient's cognitive impairment via three distinct tests: The Symbol Digit Modalities Test (SDMT), which is used as a general screening tool for severe cognitive dysfunction; the Brief Visuospatial Memory Test Revised (BVMT-R); and Rey Auditory Verbal Learning Test (RAVLT). Each test scores range from 0 - 110, 12 or 36 respectively, with lower scores indicating more serious levels of mental deterioration."

Answered by AI

Are there any remaining vacancies for test subjects in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently in search of participants - the first posting was on January 18th 2022 and it has been updated most recently on September 13th 2022. The study requires 50 volunteers at 1 particular site."

Answered by AI

May I partake in the research project?

"This medical research requires the participation of 50 individuals between 23 and 59 years old who have been diagnosed with multiple sclerosis. Furthermore, these patients must either possess radiologically isolated syndrome that has lasted no more than 6 months from their initial MRI scan or clinically isolated syndrome ≤ 3 months from first clinical event for eligibility."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
New York
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

wanting to support MS research and Trials.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

what are details to trials?
PatientReceived 1 prior treatment
~2 spots leftby Jun 2024