Impact of tDCS on Cerebral Autoregulation
Primary Purpose
Cerebral Microangiopathy, CADASIL, Migraine With Aura
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Anodal tDCS
Cathodal tDCS
sham tDCS
Sponsored by
About this trial
This is an interventional basic science trial for Cerebral Microangiopathy
Eligibility Criteria
Inclusion Criteria:
- severe cerebral Microangiopathy
- NOTCH3 carrier
- Migraine with aura (IHS Classification ICHD-II)
- 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%,
Sites / Locations
- Department of Neurology, Charité Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Anodal tDCS
Cathodal tDCS
Sham tDCS
Arm Description
anaodal transcranial direct current stimulation
cathodal transcranial direct current stimulation
no stimulation
Outcomes
Primary Outcome Measures
Cerebral vasomotor reactivity assessed by transcranial Dopplersonography
comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation
Secondary Outcome Measures
Full Information
NCT ID
NCT01865604
First Posted
December 18, 2012
Last Updated
March 15, 2016
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01865604
Brief Title
Impact of tDCS on Cerebral Autoregulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Microangiopathy, CADASIL, Migraine With Aura, ICA Stenosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS
Arm Type
Experimental
Arm Description
anaodal transcranial direct current stimulation
Arm Title
Cathodal tDCS
Arm Type
Active Comparator
Arm Description
cathodal transcranial direct current stimulation
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
no stimulation
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Type
Device
Intervention Name(s)
Cathodal tDCS
Intervention Type
Device
Intervention Name(s)
sham tDCS
Primary Outcome Measure Information:
Title
Cerebral vasomotor reactivity assessed by transcranial Dopplersonography
Description
comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation
Time Frame
on 3 days within 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
severe cerebral Microangiopathy
NOTCH3 carrier
Migraine with aura (IHS Classification ICHD-II)
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%,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, Prof. MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Impact of tDCS on Cerebral Autoregulation
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