NCT01740830

Brief Summary

The current study investigates the effects of tDCS in patients with multiple sclerosis (MS). The investigators hypothesize that anodal tDCS will increase motor performance in patients with MS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

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

June 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

4 months

First QC Date

November 26, 2012

Last Update Submit

June 1, 2013

Conditions

Anodal tDCSRecruitment Curves

Outcome Measures

Primary Outcomes (1)

  • Motor performance on a unimanual sequence learning task

    Patients were instructed to perform a unimanual sequence-learning task consisting of sequential finger presses. The following parameters were measured: Correct sequences/mean inter tap interval (ITI), percentage correct key presses/mean ITI, percentage correct sequences, percentage correct key presses, mean ITI, and mean correct sequences in the performance interval.

    Baseline, during training and POST (30 min after baseline) intervention

Study Arms (2)

Anodal tDCS

ACTIVE COMPARATOR
Device: Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)

Sham tDCS

SHAM COMPARATOR
Device: Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)

Interventions

Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)DEVICE

The anode will be fixed over the primary motor cortex. The cathode will be fixed over the contralateral supraorbital region.

Also known as: Neuroconn DC-stimulator
Anodal tDCSSham tDCS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old
  • male and female

You may not qualify if:

  • relapse in the last 3 months
  • when not suitable for tDCS (screening)
  • if TMS measures can not be completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs. Koen Cuypers

Study Record Dates

First Submitted

November 26, 2012

First Posted

December 4, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 4, 2013

Record last verified: 2013-06