Impact of tDCS on Cerebral Autoregulation

March 15, 2016 updated by: Agnes Flöel, Charite University, Berlin, Germany
The aim of the study is to investigate whether there is a polarity-specific influence of tDCS on cerebral vasomotor reactivity monitored by transcranial doppler sonography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Neurology, Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. severe cerebral Microangiopathy
  2. NOTCH3 carrier
  3. Migraine with aura (IHS Classification ICHD-II)
  4. Stenosis >80%, ECST-Criteria

Exclusion Criteria:

  • seizure disorder
  • history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity
  • dementia

(1+2) history of stroke in past 3 months (3) migraine prophylaxis (4) contralateral stenosis >50%,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal tDCS
anaodal transcranial direct current stimulation
Device: Anodal tDCS
Active Comparator: Cathodal tDCS
cathodal transcranial direct current stimulation
Device: Cathodal tDCS
Sham Comparator: Sham tDCS
no stimulation
Device: sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral vasomotor reactivity assessed by transcranial Dopplersonography
Time Frame: on 3 days within 12 weeks
comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation
on 3 days within 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Agnes Flöel, Prof. MD, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS_cVMR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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