Impact of tDCS on Cerebral Autoregulation

NCT01865604 | Completed

• 1 other identifier: tDCS_cVMR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Microangiopathy; CADASIL; Migraine With Aura; ICA Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Anodal tDCS DEVICE

Anodal tDCS

Cathodal tDCS DEVICE

Cathodal tDCS

sham tDCS DEVICE

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe cerebral Microangiopathy
• NOTCH3 carrier
• Migraine with aura (IHS Classification ICHD-II)
• Stenosis \>80%, ECST-Criteria

You may not qualify if:

• 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%,

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Neurology, Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; CADASIL; Migraine with Aura

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Dementia, Vascular; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Stroke; Dementia; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Migraine Disorders; Headache Disorders, Primary; Headache Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Agnes Flöel, Prof. MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Agnes Floeel

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: May 31, 2013
• Study Start: April 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

DE (1)