Migraine HeadacheNCT01630044
Neurostimulation Device for Treatment of Migraine Headache
A study testing TNM device in people with Migraine Headache, run by Scion NeuroStim at 1 site in United States.
Trial summary
This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- TNM device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Apr 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.)
- A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
- The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
- Subject must be at least 18 years of age.
Who cannot join
- Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury.
- A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Medicine / Neurology
Durham, North Carolina, 27705
About this study
Official title: Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache
This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.
- Conditions
- Migraine Headache
- Being tested
- TNM device
- Keywords
- caloric vestibular stimulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM deviceDevice
Non-invasive neurostimulator, home-use treatment for up to 43 days.
| Study group | Role | What they receive |
|---|---|---|
| TNM device, active treatment | Experimental | This is an active-only assessment of the experimental neuromodulation device Receives: Device: TNM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of migraine headache days
Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache.
Measured: Length of the study, about 71 days
Severity of each and of all headaches
Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain).
Measured: Length of study, 71 days
Secondary outcomes (1)
Total Monthly Headache Pain Score
The monthly measure would be the cumulative maximal headache pain scores for all headache days (days on which the subject's head pain level is one or higher on the pain measurement scale) during the month.
Measured: Length of study, about 71 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadacheStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scion NeuroStim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Laskowitz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630044
- Sponsor's protocol ID
- Pro00037089
- Status last verified
- Mar 2025
- First submitted
- 5 Jun 2012
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Black RD, Rogers LL, Ade KK, Nicoletto HA, Adkins HD, Laskowitz DT. Non-Invasive Neuromodulation Using Time-Varying Caloric Vestibular Stimulation. IEEE J Transl Eng Health Med. 2016 Oct 7;4:2000310. doi: 10.1109/JTEHM.2016.2615899. eCollection 2016.
PubMed 27777829
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache
- ClinicalTrials.gov ID
- NCT01630044
- Acronym / sponsor ID
- Pro00037089
- Conditions
- Migraine Headache
- Keywords
- caloric vestibular stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Jun 2012 (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.
This is a single-site, prospective, non-randomized and open label study to investigate the feasibility of home-use CVS for the prevention of episodic migraine headache and specifically to better understand what type of waveform to apply.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNM device, active treatment | Experimental | Device: TNM deviceThis is an active-only assessment of the experimental neuromodulation device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A history of at least four, and not more than fourteen total monthly headache days of which between four and nine were migraine headache days. (Note: Patients were permitted continued access to migraine abortive medications and were being treated at the Duke University headache clinic.)
- A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently);
- The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary.
- Subject must be at least 18 years of age.
Key exclusion criteria (2 listed)
- Individuals who were pregnant, who had a history of cardiovascular disease, who worked night shifts or who had vestibular migraine, menstrual migraine, post-traumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury.
- A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.
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 |
|---|---|---|
| TNM deviceNon-invasive neurostimulator, home-use treatment for up to 43 days. | Device | TNM device, active treatment |
Primary outcome
Number of migraine headache days
Time frame: Length of the study, about 71 days
Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache.
Severity of each and of all headaches
Time frame: Length of study, 71 days
Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain).
1 secondary outcome
Total Monthly Headache Pain Score
Time frame: Length of study, about 71 days
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 30 Mar 2025.
- Background: PubMed 27777829Black RD, Rogers LL, Ade KK, Nicoletto HA, Adkins HD, Laskowitz DT. Non-Invasive Neuromodulation Using Time-Varying Caloric Vestibular Stimulation. IEEE J Transl Eng Health Med. 2016 Oct 7;4:2000310. doi: 10.1109/JTEHM.2016.2615899. eCollection 2016.
- 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.
Daniel Laskowitz, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNM device in people with Migraine Headache, run by Scion NeuroStim at 1 site 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 4 inclusion and 2 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 30 Mar 2025. 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 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. 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?
Number of migraine headache days (time frame: Length of the study, about 71 days). The study lists 2 primary outcomes in all. 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 NCT01630044, which also lists 1 linked publication.
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 30 Mar 2025.