Migraine DisordersNCT03874351
A Study of Home-Delivered Neurostimulation for Migraine
A study testing non-invasive transcranial direct current stimulation (tDCS) in people with Migraine Disorders, run by MJHS Institute for Innovation in Palliative Care at 2 sites in United States.
Trial summary
There is a need for better preventive and abortive therapies for migraine. Previous research has indicated that non-invasive neurostimulation may have prophylactic effects on migraine and improve symptoms and functional outcomes in migraineurs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- non-invasive transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2019to 12 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years;
- Has episodic or chronic migraine with or without aura, diagnosed according to the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria, for at least the past 12 months;
- Migraine occurring on 4 or more days per month, as documented through the 30-day baseline;
- No change in prophylactic therapy in 3 months preceding the baseline;
- If on antidepressant, blood pressure or epilepsy medication for reason other than migraine, the medication regimen is stable for at least 3 months preceding the baseline; Able to follow instructions in English;
- Understand the informed consent process and provide consent to participate in the study.
Who cannot join
- History of severe head trauma, brain surgery, implants in the head or neck; history of seizures;
- Skin disorder or skin defects which compromise the integrity or sensitivity of the skin at or near locations where tDCS will be applied;
- Not able to prepare and operate the tDCS device after being instructed in tDCS use;
- Not able to respond to questionnaires and rating scales;
- Concurrent use of another neurostimulation device (such as spinal cord stimulator cardiostimulator, deep brain stimulator, vagus nerve, transcranial magnetic, or supraorbital transcutaneous electric nerve stimulators);
- Concurrent use of Botox or calcitonin gene-related peptide (CGRP) monoclonal antibodies treatments;
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- Unstable acute medical condition;
- Any serious, malignant or non-malignant, acute or chronic medical condition or active psychiatric illness that, in the Investigator's opinion, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study;
- Used any investigational drug, biologic, or device within 30 days prior to screening, or 5 half-lives, whichever is longer;
- Taking opioid analgesics or barbiturates on more than 2 days a week;
- Taking medications acting as antagonist on the N-methyl-D-aspartate (NMDA) receptor.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MJHS Institute for Innovation in Palliative Care
New York, New York, 10006
New York Headache Center
New York, New York, 10021
About this study
Official title: A Randomized Sham-Controlled Study of Home-Delivered Non-Invasive Neurostimulation for Migraine
There is a need for better preventive and abortive therapies for migraine. Previous research has indicated that non-invasive neurostimulation may have prophylactic effects on migraine and improve symptoms and functional outcomes in migraineurs. One such method is a non-invasive transcranial direct current stimulation (tDCS). This double-blind randomized sham-controlled two-parallel-arm study aims to evaluate efficacy and safety of tDCS self-delivered in daily 20-minute applications for 2 months (60 days) by adult migraine patients at home for migraine prevention and migraine symptom management, as compared to sham tDCS application; and to evaluate patients' satisfaction with the procedure.
Read the detailed description
This study will employ a double-blind randomized sham-controlled two-parallel-arm design and involve 60 adults with migraine. For each participant, the study will involve 3 study visits and last about 90 days (30 days of the baseline followed by 60 days of the tDCS/sham study intervention). A post-study safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.
At Visit 1, patients will provide written informed consent and undergo screening for the eligibility. This will be followed by 30 days of baseline at home during which patients will keep daily records (Daily Diaries) of migraine occurrence and provide answers to a set of symptom-related questionnaires. Patients with 4 or more migraine days per month who fully meet the study eligibility criteria at the end of the baseline period will be randomized in double-blind manner into two groups: Group 1 will be randomized to receive active tDCS in daily 20-minute applications for 60 days; Group 2 will be randomized to receive sham tDCS in daily 20-minute applications for 60 days, self-applied at home. Following randomization, patients will continue keeping the Daily Diaries and Visit #2 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be deployed to the patient and instructions on tDCS use will be provided. The first tDCS/sham self-application by the patient will be done at Visit 2. Daily tDCS/sham self-application by the patient at home and records in the form of Daily Diaries will continue for the rest of the 60-day period. Study staff will be in regular remote contact with the patient via phone and/or HIPAA-compliant videoconferencing. Upon conclusion of the intervention, Visit 3 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be collected from the patient. Safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.
Outcome assessment will be carried out at the end of the baseline, and at Day 30 (the secondary time-point) and Day 60 (the primary time-point) of the tDCS/sham intervention.
- Conditions
- Migraine Disorders
- Being tested
- non-invasive transcranial direct current stimulation (tDCS)
- Keywords
- Migraine;, transcranial direct current stimulation (tDCS), tDCS-Telehealth intervention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive transcranial direct current stimulation (tDCS)Device
Active tDCS: transcranial direct current stimulation at intensity 1.5mA for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
Sham tDCS: transcranial direct current stimulation at intensity 1.5mA for 30seconds followed by 0 mA current for remaining time of the 20-minute intervention per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Twenty minutes of direct current at intensity of 1.5 milliamperes (mA). Receives: Device: non-invasive transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | Thirty seconds of direct current at 1.5 mA, followed by 0 mA for the remaining time of the 20-minute stimulation period. Receives: Device: non-invasive transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Days Per Month
A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day.
Measured: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);
Secondary outcomes (8)
Percentage of Responders
determined as a percentage of patients having at least 50% reduction of monthly migraine days between the one-month baseline and post-intervention, in each of the two study groups
Measured: Day 60 of the intervention
Migraine Attack Frequency
Median change in number of attacks per 30-day period, determined from the patients' diaries
Measured: Baseline, Day 30 of the intervention, Day 60 of the intervention
Acute Medication Use
Acute antimigraine drug use per month determined from the patient's diaries. Median change in number of days on which an acute medication was used.
Measured: Baseline, Day 30 of the intervention, Day 60 of the intervention
Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period
Determined from the 11-point [0-10] Pain Numerical Rating Scale (Pain NRS) on migraine days in the patients' diaries. Higher ratings on the Pain NRS reflect higher intensity of pain.
Measured: Baseline, Day 30 of the intervention, Day 60 of the intervention;
Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)
Determined from ratings on the migraine-specific MSQ questionnaire. The questionnaire consists of 14 items, each rated on a scale 1-6, with the total score ranging between 14 and 84. Higher scores reflect poorer quality of life.
Measured: Baseline, Day 30 of the intervention, Day 60 of the intervention;
Change in Depressive Symptoms
Determined from the Hamilton Depression Scale (HamD) that consists of 21 items with numerically rated responses ranging 0-2 or 0-4. Higher Ham-D score reflects more severe depression.
Measured: Baseline, Day 30 of the intervention, Day 60 of the intervention;
Tolerability of the Study Intervention: Number of Side Effects and Adverse Events
Determined as number of side effects and adverse events related, probably related or possibly related to the study intevention
Measured: from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application
Patient's Satisfaction: 8-item tDCS User Survey
Patient's satisfaction with the study intervention determined from the 8-item tDCS User Survey at the end of the intervention. Each item of the Survey is a brief statement and a respondent indicates if s/he Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree with the statement. Higher number of Agree/Strongly Agree ratings reflects higher satisfaction with the tDCS procedure.
Measured: Day 60 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start22 Apr 2019
- Primary completion13 Apr 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MJHS Institute for Innovation in Palliative Care
- Sponsor type
- University, hospital or other
- Collaborators
- New York Headache Center
- Responsible party
- Sponsor
- Investigators
- Helena Knotkova, PhD, Principal investigator, MJHS Institute for Innovation in Palliative Care (MJHSPalliative)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874351
- Sponsor's protocol ID
- 19008-01
- Status last verified
- Dec 2021
- First submitted
- 12 Mar 2019
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-Controlled Study of Home-Delivered Non-Invasive Neurostimulation for Migraine
- ClinicalTrials.gov ID
- NCT03874351
- Acronym / sponsor ID
- 19008-01
- Conditions
- Migraine Disorders
- Keywords
- Migraine;, transcranial direct current stimulation (tDCS), tDCS-Telehealth intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MJHS Institute for Innovation in Palliative CareUniversity, hospital or other
- Collaborators
- New York Headache Center
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Posted 2 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a need for better preventive and abortive therapies for migraine. Previous research has indicated that non-invasive neurostimulation may have prophylactic effects on migraine and improve symptoms and functional outcomes in migraineurs. One such method is a non-invasive transcranial direct current stimulation (tDCS). This double-blind randomized sham-controlled two-parallel-arm study aims to evaluate efficacy and safety of tDCS self-delivered in daily 20-minute applications for 2 months (60 days) by adult migraine patients at home for migraine prevention and migraine symptom management, as compared to sham tDCS application; and to evaluate patients' satisfaction with the procedure.
Detailed description
This study will employ a double-blind randomized sham-controlled two-parallel-arm design and involve 60 adults with migraine. For each participant, the study will involve 3 study visits and last about 90 days (30 days of the baseline followed by 60 days of the tDCS/sham study intervention). A post-study safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.
At Visit 1, patients will provide written informed consent and undergo screening for the eligibility. This will be followed by 30 days of baseline at home during which patients will keep daily records (Daily Diaries) of migraine occurrence and provide answers to a set of symptom-related questionnaires. Patients with 4 or more migraine days per month who fully meet the study eligibility criteria at the end of the baseline period will be randomized in double-blind manner into two groups: Group 1 will be randomized to receive active tDCS in daily 20-minute applications for 60 days; Group 2 will be randomized to receive sham tDCS in daily 20-minute applications for 60 days, self-applied at home. Following randomization, patients will continue keeping the Daily Diaries and Visit #2 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be deployed to the patient and instructions on tDCS use will be provided. The first tDCS/sham self-application by the patient will be done at Visit 2. Daily tDCS/sham self-application by the patient at home and records in the form of Daily Diaries will continue for the rest of the 60-day period. Study staff will be in regular remote contact with the patient via phone and/or HIPAA-compliant videoconferencing. Upon conclusion of the intervention, Visit 3 will be held either in the patient's home or in the research facility, based on the patient's preference. tDCS device will be collected from the patient. Safety monitoring will continue bi-weekly by phone for 30 days after the last tDCS/sham application.
Outcome assessment will be carried out at the end of the baseline, and at Day 30 (the secondary time-point) and Day 60 (the primary time-point) of the tDCS/sham intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: non-invasive transcranial direct current stimulation (tDCS)Twenty minutes of direct current at intensity of 1.5 milliamperes (mA). |
| Sham tDCS | Sham comparator | Device: non-invasive transcranial direct current stimulation (tDCS)Thirty seconds of direct current at 1.5 mA, followed by 0 mA for the remaining time of the 20-minute stimulation period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 - 65 years;
- Has episodic or chronic migraine with or without aura, diagnosed according to the International Classification of Headache Disorders 3rd edition (ICHD-3) criteria, for at least the past 12 months;
- Migraine occurring on 4 or more days per month, as documented through the 30-day baseline;
- No change in prophylactic therapy in 3 months preceding the baseline;
- If on antidepressant, blood pressure or epilepsy medication for reason other than migraine, the medication regimen is stable for at least 3 months preceding the baseline; Able to follow instructions in English;
Key exclusion criteria (11 listed)
- History of severe head trauma, brain surgery, implants in the head or neck; history of seizures;
- Skin disorder or skin defects which compromise the integrity or sensitivity of the skin at or near locations where tDCS will be applied;
- Not able to prepare and operate the tDCS device after being instructed in tDCS use;
- Not able to respond to questionnaires and rating scales;
- Concurrent use of another neurostimulation device (such as spinal cord stimulator cardiostimulator, deep brain stimulator, vagus nerve, transcranial magnetic, or supraorbital transcutaneous electric nerve stimulators);
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 |
|---|---|---|
| non-invasive transcranial direct current stimulation (tDCS)Active tDCS: transcranial direct current stimulation at intensity 1.5mA for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. Sham tDCS: transcranial direct current stimulation at intensity 1.5mA for 30seconds followed by 0 mA current for remaining time of the 20-minute intervention per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right. | Device | Active tDCS, Sham tDCS |
Primary outcome
Migraine Days Per Month
Time frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);
A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day.
8 secondary outcomes
Percentage of Responders
Time frame: Day 60 of the intervention
Migraine Attack Frequency
Time frame: Baseline, Day 30 of the intervention, Day 60 of the intervention
Acute Medication Use
Time frame: Baseline, Day 30 of the intervention, Day 60 of the intervention
Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period
Time frame: Baseline, Day 30 of the intervention, Day 60 of the intervention;
Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)
Time frame: Baseline, Day 30 of the intervention, Day 60 of the intervention;
Change in Depressive Symptoms
Time frame: Baseline, Day 30 of the intervention, Day 60 of the intervention;
Tolerability of the Study Intervention: Number of Side Effects and Adverse Events
Time frame: from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS application
Patient's Satisfaction: 8-item tDCS User Survey
Time frame: Day 60 of the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Helena Knotkova, PhD principal investigator
MJHS Institute for Innovation in Palliative Care (MJHSPalliative)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive transcranial direct current stimulation (tDCS) in people with Migraine Disorders, run by MJHS Institute for Innovation in Palliative Care at 2 sites in United States.
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 6 inclusion and 11 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 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Per Month (time frame: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);). 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 17 Dec 2021.