Impact of tDCS on Cerebral Autoregulation | NCT01865604

Studies
Impact of tDCS on Cerebral Autoregulation

NCT01865604

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Mar 16, 2016Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Cerebral Microangiopathy
CADASIL
Migraine With Aura
ICA Stenosis

Interventions

Anodal tDCS
Cathodal tDCS
sham tDCS

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

May 28, 2013

First Posted Date

May 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2016

Last Update Posted Date

Mar 16, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Agnes Flöel, Prof. Dr. med. Agnes Floeel, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anodal tDCS	Experimental	anaodal transcranial direct current stimulation	Device: Anodal tDCS
Cathodal tDCS	Active Comparator	cathodal transcranial direct current stimulation	Device: Cathodal tDCS
Sham tDCS	Sham Comparator	no stimulation	Device: sham tDCS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anodal tDCS	Device		Anodal tDCS
Cathodal tDCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral vasomotor reactivity assessed by transcranial Dopplersonography	comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation	on 3 days within 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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%,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agnes Flöel, Prof. MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Charité Universitätsmedizin Berlin		Berlin	State of Berlin	10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D059345	Cerebral Small Vessel Diseases
D046589	CADASIL
D020325	Migraine with Aura

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

Not provided

Browse Branches

Not provided