Double-blind DesignNCT03237754
Neurostimulation in Chronic and Episodic Migraine
A study testing tDCS device from neuroConn in people with Double-blind Design and Sham-controlled, run by University of Zurich at 1 site in Switzerland.
Trial summary
Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic) drug therapy. In contrast, neurophysiologically guided treatments might provide an alternative avenue, since these can normalize brain alterations without side effects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Double-blind Design, Sham-controlled, Randomized
- What is being tested?
- tDCS device from neuroConn
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2016to 30 May 2020
- 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
- Patients from age 18 upwards (max. 80 years) suffering from chronic or episodic migraine. Medication overuse headache (MOH) patients are included as well (as chronic migraine patients do often show MOH).
- Healthy volunteers (18-80 years) are included if they don't fulfil the exclusion criteria and do not suffer from migraine or other headache disorders, except infrequent episodic tension-type headache All volunteers are able to read and sign the informed consent.
Who cannot join
- Patients and healthy volunteers are excluded if they fulfil one of the following exclusion criteria:
- Common MR exclusion criteria: such as metallic items in the body (i.e. eye splinter, MR incompatible implants), pacemaker, claustrophobia or obesity (body mass index > 35).
- Also pregnant participants and participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease will be excluded. Participants with major psychiatric disorders such as schizophrenia, bipolar disorder will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation
Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic) drug therapy. In contrast, neurophysiologically guided treatments might provide an alternative avenue, since these can normalize brain alterations without side effects. Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic treatment of migraine, probably because of its modifying and re-balancing influence on neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it is necessary to apply not only tDCS but also a "sham" placebo, which is often neglected in tDCS stimulation studies. Further, tDCS needs to be applied in a large (n > 20) sample of well-defined migraine patients, which would be advantageous, compared to previously published work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS is essential to investigate physiological mechanisms of tDCS. There is an increasing interest towards non-pharmacological treatment alternatives for migraine (and headache disorders) with reduced side effects to established prophylactic medications. The primary outcome of this project is to demonstrate that repetitive sessions of neurostimulation lead to a significant and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays accepted as therapeutic tools, our study might provide evidence that tDCS can be a non-pharmacological alternative for treating migraine.
- Conditions
- Double-blind Design, Sham-controlled, Randomized
- Being tested
- tDCS device from neuroConn
- Keywords
- migraine, neurostimulation, neuroimaging, tDCS, MRI
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS device from neuroConnDevice
weak electrical direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real Neurostimulation | Experimental | 4 weeks of neurostimulation (using tDCS) Receives: Device: tDCS device from neuroConn |
| Sham Neurostimulation | Sham comparator | 4 weeks of sham Treatment with the same device used for real neurostimulation Receives: Device: tDCS device from neuroConn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine days
Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group
Measured: 6 months
Secondary outcomes (2)
MR data
Changes in functional and structural MR data before and after tDCS Treatment
Measured: 6 months
Clinical data
Clinical variables (e.g. depression scores) will be compared in an identical fashion as for the variable "migraine days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Oct 2016
- Primary completion30 May 2020
- Study completion30 May 2020
Why it stopped: Recruitment problems (especially for chronic migraine patients)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Double-blind DesignStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Patients receive either Placebo or real neurostimulation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baden
- Responsible party
- Sponsor
- Investigators
- Lars Michels, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237754
- Sponsor's protocol ID
- 2016-00646
- Other IDs
- 2016
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2017
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pohl H, Sandor PS, Moisa M, Ruff CC, Schoenen J, Luechinger R, O'Gorman R, Riederer F, Gantenbein AR, Michels L. Occipital transcranial direct current stimulation in episodic migraine patients: effect on cerebral perfusion. Sci Rep. 2023 Aug 25;13(1):13944. doi: 10.1038/s41598-023-39659-5.
PubMed 37626074Schading S, Pohl H, Gantenbein A, Luechinger R, Sandor P, Riederer F, Freund P, Michels L. Tracking tDCS induced grey matter changes in episodic migraine: a randomized controlled trial. J Headache Pain. 2021 Nov 20;22(1):139. doi: 10.1186/s10194-021-01347-y.
PubMed 34800989
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neuronal Changes in Chronic and Episodic Migraine Patients After Neurostimulation
- ClinicalTrials.gov ID
- NCT03237754
- Acronym / sponsor ID
- 2016-00646
- Conditions
- Double-blind Design, Sham-controlled, Randomized
- Keywords
- migraine, neurostimulation, neuroimaging, tDCS, MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems (especially for chronic migraine patients)
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Kantonsspital Baden
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 3 Aug 2017 (actual)
- 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.
Currently, successful prevention of migraine is not sufficiently achieved by (prophylactic) drug therapy. In contrast, neurophysiologically guided treatments might provide an alternative avenue, since these can normalize brain alterations without side effects. Transcranial direct current stimulation (tDCS) appears useful in the acute and prophylactic treatment of migraine, probably because of its modifying and re-balancing influence on neuronal activity. Yet, to test for the efficacy of tDCS in a clinically acceptable way, it is necessary to apply not only tDCS but also a "sham" placebo, which is often neglected in tDCS stimulation studies. Further, tDCS needs to be applied in a large (n > 20) sample of well-defined migraine patients, which would be advantageous, compared to previously published work. Monitoring sources of regional neuronal alterations in migraineurs prior and after tDCS is essential to investigate physiological mechanisms of tDCS. There is an increasing interest towards non-pharmacological treatment alternatives for migraine (and headache disorders) with reduced side effects to established prophylactic medications. The primary outcome of this project is to demonstrate that repetitive sessions of neurostimulation lead to a significant and permanent reduction of the primary symptom severity (i.e. migraine attacks) for patients suffering from chronic and episodic migraine. Since neurostimulation tools are nowadays accepted as therapeutic tools, our study might provide evidence that tDCS can be a non-pharmacological alternative for treating migraine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients receive either Placebo or real neurostimulation
| Arm | Type | Receives |
|---|---|---|
| Real Neurostimulation | Experimental | Device: tDCS device from neuroConn4 weeks of neurostimulation (using tDCS) |
| Sham Neurostimulation | Sham comparator | Device: tDCS device from neuroConn4 weeks of sham Treatment with the same device used for real neurostimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients from age 18 upwards (max. 80 years) suffering from chronic or episodic migraine. Medication overuse headache (MOH) patients are included as well (as chronic migraine patients do often show MOH).
- Healthy volunteers (18-80 years) are included if they don't fulfil the exclusion criteria and do not suffer from migraine or other headache disorders, except infrequent episodic tension-type headache All volunteers are able to read and sign the informed consent.
Key exclusion criteria (3 listed)
- Patients and healthy volunteers are excluded if they fulfil one of the following exclusion criteria:
- Common MR exclusion criteria: such as metallic items in the body (i.e. eye splinter, MR incompatible implants), pacemaker, claustrophobia or obesity (body mass index > 35).
- Also pregnant participants and participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease will be excluded. Participants with major psychiatric disorders such as schizophrenia, bipolar disorder will also be excluded.
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 |
|---|---|---|
| tDCS device from neuroConnweak electrical direct current stimulation | Device | Real Neurostimulation, Sham Neurostimulation |
Primary outcome
Migraine days
Time frame: 6 months
Change in migraine days (in episodic and chronic migraine patients) after tDCS Treatment (relative to before tDCS)Treatment) in the active and Placebo group
2 secondary outcomes
MR data
Time frame: 6 months
Clinical data
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment problems (especially for chronic migraine patients)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Derived from this study: PubMed 37626074Pohl H, Sandor PS, Moisa M, Ruff CC, Schoenen J, Luechinger R, O'Gorman R, Riederer F, Gantenbein AR, Michels L. Occipital transcranial direct current stimulation in episodic migraine patients: effect on cerebral perfusion. Sci Rep. 2023 Aug 25;13(1):13944. doi: 10.1038/s41598-023-39659-5.
- Derived from this study: PubMed 34800989Schading S, Pohl H, Gantenbein A, Luechinger R, Sandor P, Riederer F, Freund P, Michels L. Tracking tDCS induced grey matter changes in episodic migraine: a randomized controlled trial. J Headache Pain. 2021 Nov 20;22(1):139. doi: 10.1186/s10194-021-01347-y.
- Individual participant dataSharing planned: Undecided
Related trials for Double-blind Design
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Active, not recruiting
Product Responsiveness to Enhanced Bioavailability Curcumin Dietary Supplements in Adults
Joint Discomfort, Quality of Life (QOL)
Not yet recruitingPhase 3
A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Idiopathic Inflammatory Myopathies
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations
NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
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.
Lars Michels, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS device from neuroConn in people with Double-blind Design and Sham-controlled, run by University of Zurich at 1 site in Switzerland.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Aug 2020. 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 Switzerland. 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 was stopped early (reason given: Recruitment problems (especially for chronic migraine patients)). Results are not available in the source record.
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?
Migraine days (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03237754, which also lists 2 linked publications.
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 28 Aug 2020.