- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01899040
A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache
4 maj 2018 uppdaterad av: Scion NeuroStim
This is a randomized, blinded study designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of episodic migraine headaches.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
81
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
California
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San Diego, California, Förenta staterna, 92134
- Naval Medical Center
-
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48104
- Michigan Headache and Neurological Institute
-
-
North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27516
- Carolina Headache Institute
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Durham, North Carolina, Förenta staterna, 27705
- Duke University
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Greensboro, North Carolina, Förenta staterna, 27405
- Headache Wellness Center
-
-
-
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Canterbury
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Kent, Canterbury, Storbritannien, CT2 7NP
- Kent University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
INCLUSION CRITERIA:
- The patient must have been diagnosed with episodic Migraine Headache at least 6 months prior to entering into the Study, consistent with the International Headache Classification of Headache Disorders-II (ICHD-II) guidelines.
- The patient must have a history of at least three consecutive months of stable Migraine Headaches prior to entering the Study. The patients will not have had changes in medication usage for the three Months leading up to the Study, nor will they introduce new medications during the Study period. Patients will satisfy these criteria: On a Monthly basis, at least four, and not more than a total of fourteen (4-14), Headache Days (Pain Score between one and ten) of which between four and nine (4-14) are Migraine Headache Days
- The patient must not have failed on more than two classes of properly administered prophylactic pharmaceutical therapies for migraine headache. The patient may be on a single migraine prophylactic as long as the dosage has not been altered within 3 months of starting the study and the dosage must not be altered for the duration of the study.
- The Investigator must have confidence in the patient's ability to reliably use the Experimental Device and promptly complete the Daily Headache Diary forms. The Daily Headache Diary will be completed from the beginning of the Pre-Treatment Baseline Period through the end of the Pivotal Study.
EXCLUSION CRITERIA:
Individuals who:
- are pregnant
- have a history of cardiovascular disease
- work night shifts
- have been diagnosed with vestibular migraine
- have been diagnosed with migraine with aura
- have menstrual migraine exclusively
- have been diagnosed with post-traumatic migraine
- have a history of unstable mood disorder or unstable anxiety disorder
- use a hearing aid
- have a cochlear implant
- have chronic tinnitus
- have temporomandibular joint disease
- have been diagnosed with traumatic brain injury
- have been diagnosed with neurological disease other than Headaches
- have a diagnosed vestibular dysfunction
- abuse alcohol or other drugs
- are experiencing medication overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
- are less than 18 years old or greater than 65 years old
- have had eye surgery within the previous three months or ear surgery within the previous six months
- have active ear infections or a perforated tympanic membrane
- have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
- are using Botox treatments for migraines
- Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to using the Device. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness to stimulation. Such medications should also be avoided within four hours prior to a treatment.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: active device
A standardized active neuromodulation waveform will be used for all active Device patients at all Study sites.
The Device will be used twice daily.
|
|
Placebo-jämförare: placebo device
A standardized placebo neuromodulation waveform will be used for all placebo Device patients at all Study sites.
The Device will be used twice daily.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of monthly migraine headache days
Tidsram: after 84 days of Device use
|
During the third Month of Device use, the average total number of Monthly Migraine Headache Days will be lower than comparable averages derived from the Pre-use Baseline Period
|
after 84 days of Device use
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of monthly migraine headache days (reduction by by 50% or more)
Tidsram: after 84 days of Device use
|
A reduction of 50% or more in monthly Migraine Headache Days during the third Month of Device use as compared with the Pre-use Baseline Period.
|
after 84 days of Device use
|
Total monthly pain score
Tidsram: after 84 days of Device use
|
During the third Month of Device use, the average Total Monthly Headache Pain Scores will be lower than comparable averages derived from the Pre-use Baseline Period.
|
after 84 days of Device use
|
Mood and cognition measures - Change in mood scores
Tidsram: after 84 days of Device use
|
A patient's Pre-use Baseline Period mood scores will be compared with those at the end of the Device use period.
Mood scores will be assessed for: a decline, no change, or an improvement.
|
after 84 days of Device use
|
Verify the absence of material dizziness
Tidsram: after 84 days of Device use
|
The principal safety endpoint for the Study is to verify the absence of material dizziness, with the associated risk of falls, as a consequence of using the Device.
|
after 84 days of Device use
|
Mood and cognition measures - Change in cognitive speed scores
Tidsram: after 84 days of Device use
|
A patient's Pre-use Baseline Period cognitive speed scores will be compared with those at the end of the Device use period.
Cognitive speed scores will be assessed for: a decline, no change, or an improvement.
|
after 84 days of Device use
|
Mood and cognition measures - Change in memory scores
Tidsram: after 84 days of Device use
|
A patient's Pre-use Baseline Period memory scores will be compared with those at the end of the Device use period.
Memory scores will be assessed for: a decline, no change, or an improvement.
|
after 84 days of Device use
|
Use of acute medications - change in number of treated headaches
Tidsram: after 84 days of device use
|
During the third month of device use, the number of abortive medications taken will be less than the number taken in the baseline month
|
after 84 days of device use
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Lesco Rogers, MD, Scion NeuroStim
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2013
Primärt slutförande (Faktisk)
1 maj 2016
Avslutad studie (Faktisk)
1 juni 2016
Studieregistreringsdatum
Först inskickad
29 juni 2013
Först inskickad som uppfyllde QC-kriterierna
10 juli 2013
Första postat (Uppskatta)
15 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2018
Senast verifierad
1 maj 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SNS-MIG-01
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