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Impact of tDCS on Cerebral Autoregulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01865604
First received: December 18, 2012
Last updated: March 26, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cerebral vasomotor reactivity assessed by transcranial Dopplersonography [ Time Frame: on 3 days within 12 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 18, 2012
Last Updated: March 26, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cerebral Small Vessel Diseases
Migraine with Aura
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Headache Disorders
Headache Disorders, Primary
Migraine Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014