Cerebral MicroangiopathyNCT01865604
Impact of tDCS on Cerebral Autoregulation
A study testing Anodal tDCS and Cathodal tDCS in people with Cerebral Microangiopathy and CADASIL, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Microangiopathy, CADASIL, Migraine With Aura
- What is being tested?
- Anodal tDCS and Cathodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- severe cerebral Microangiopathy
- NOTCH3 carrier
- Migraine with aura (IHS Classification ICHD-II)
- Stenosis >80%, ECST-Criteria
Who cannot join
- 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%,
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
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
- Being tested
- Anodal tDCS, Cathodal tDCS, sham tDCS
- Medical subject headings
- Cerebral Small Vessel Diseases, CADASIL, Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Cathodal tDCSDevice
sham tDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | anaodal transcranial direct current stimulation Receives: Device: Anodal tDCS |
| Cathodal tDCS | Active comparator | cathodal transcranial direct current stimulation Receives: Device: Cathodal tDCS |
| Sham tDCS | Sham comparator | no stimulation Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral vasomotor reactivity assessed by transcranial Dopplersonography
comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation
Measured: on 3 days within 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral MicroangiopathyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Flöel, Prof. MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865604
- Sponsor's protocol ID
- tDCS_cVMR
- Status last verified
- Mar 2016
- First submitted
- 18 Dec 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of tDCS on Cerebral Autoregulation
- ClinicalTrials.gov ID
- NCT01865604
- Acronym / sponsor ID
- tDCS_cVMR
- Conditions
- Cerebral Microangiopathy, CADASIL, Migraine With Aura, ICA Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Anodal tDCSanaodal transcranial direct current stimulation |
| Cathodal tDCS | Active comparator | Device: Cathodal tDCScathodal transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Device: sham tDCSno stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- severe cerebral Microangiopathy
- NOTCH3 carrier
- Migraine with aura (IHS Classification ICHD-II)
- Stenosis >80%, ECST-Criteria
Key exclusion criteria (4 listed)
- 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%,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCS | Device | Anodal tDCS |
| Cathodal tDCS | Device | Cathodal tDCS |
| sham tDCS | Device | Sham tDCS |
Primary outcome
Cerebral vasomotor reactivity assessed by transcranial Dopplersonography
Time frame: on 3 days within 12 weeks
comparing cerebral vasomotor reactivity at baseline and after anodal/cathodal/sham stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Flöel, Prof. MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS and Cathodal tDCS in people with Cerebral Microangiopathy and CADASIL, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral vasomotor reactivity assessed by transcranial Dopplersonography (time frame: on 3 days within 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.