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Impact of tDCS on Cerebral Autoregulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865604
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of tDCS on Cerebral Autoregulation
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Cerebral Microangiopathy
  • CADASIL
  • Migraine With Aura
  • ICA Stenosis
Intervention  ICMJE
  • Device: Anodal tDCS
  • Device: Cathodal tDCS
  • Device: sham tDCS
Study Arms  ICMJE
  • Experimental: Anodal tDCS
    anaodal transcranial direct current stimulation
    Intervention: Device: Anodal tDCS
  • Active Comparator: Cathodal tDCS
    cathodal transcranial direct current stimulation
    Intervention: Device: Cathodal tDCS
  • Sham Comparator: Sham tDCS
    no stimulation
    Intervention: Device: sham tDCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2014)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2013)
120
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%,

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865604
Other Study ID Numbers  ICMJE tDCS_cVMR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agnes Flöel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnes Flöel, Prof. MD Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP