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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
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Microangiopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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%,

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

First Posted
December 18, 2012
Last Updated
March 15, 2016
Sponsor
Charite University, Berlin, Germany
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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

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Impact of tDCS on Cerebral Autoregulation

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