Impact of tDCS on Cerebral Autoregulation

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT01865604
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 23
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Microangiopathy; CADASIL; Migraine With Aura; ICA Stenosis	Device: Anodal tDCS; Device: Cathodal tDCS; Device: sham tDCS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Cerebral vasomotor reactivity assessed by transcranial Dopplersonography [on 3 days within 12 weeks]

   comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Agnes Flöel, Prof. Dr. med. Agnes Floeel, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT01865604
• Other Study ID Numbers: tDCS_cVMR
• First Posted: May 31, 2013
• Last Update Posted: Mar 16, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Migraine with Aura; CADASIL; Cerebral Small Vessel Diseases

Study Results

No Results Posted as of Mar 16, 2016