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Impact of tDCS on Cerebral Autoregulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01865604
First Posted: May 31, 2013
Last Update Posted: March 16, 2016
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.
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention
Cerebral Microangiopathy CADASIL Migraine With Aura ICA Stenosis Device: Anodal tDCS Device: Cathodal tDCS Device: sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Agnes Flöel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: April 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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%,

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865604


Locations
Germany
Department of Neurology, Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Flöel, Prof. MD Charite University, Berlin, Germany
  More Information

Responsible Party: Agnes Flöel, Prof. Dr. med. Agnes Floeel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01865604     History of Changes
Other Study ID Numbers: tDCS_cVMR
First Submitted: December 18, 2012
First Posted: May 31, 2013
Last Update Posted: March 16, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
CADASIL
Dementia, Vascular
Dementia
Migraine with Aura
Cerebral Small Vessel Diseases
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, Inborn