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The objective of this pilot open trial was to assess the efficacy and safety of external trigeminal nerve stimulation (e-TNS) with the Cefaly® device in fibromyalgia.
The main objective of this clinical pilot trial was to evaluate the use of external trigeminal nerve stimulation (e-TNS) with the Cefaly® neurostimulator device as a new therapeutic treatment for fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefaly active device | Experimental | 12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefaly | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint | Pain intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) pain score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). | between baseline and 12-week timepoint |
| Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. | between baseline and 12-week timepoint |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint | Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). | between baseline and 4-week timepoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley Arnold, M.D. | University of Cincinnati | Principal Investigator |
| Pierre Rigaux | Cefaly Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cefaly Active Device | 12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4-week Treatment Period |
|
| |||||||||||||||||||||
| 12-week Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cefaly Active Device | 12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint | Pain intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) pain score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). | Posted | Mean | Standard Deviation | score on a scale | between baseline and 12-week timepoint |
|
|
The data was collected during the 12 weeks of the treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | 12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Department director | CEFALY Technology | +32 4 367 67 22 | info@cefaly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2015 | Jul 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. | between baseline and 4-week timepoint |
| Patient Global Impression of Change (PGIC) at 4-week Timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). | at 4-week timepoint |
| Patient Global Impression of Change (PGIC) at 12-week Timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). | at 12-week timepoint |
| Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). | between baseline and 4-week timepoint |
| Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). | between baseline and 12-week timepoint |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. | between baseline and 4-week timepoint |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. | between baseline and 12-week timepoint |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. | between baseline and 4-week timepoint |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. | between baseline and 12-week timepoint |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. | between baseline and 4-week timepoint |
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. | between baseline and 12-week timepoint |
| Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. | between baseline and 4-week timepoint |
| Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. | between baseline and 12-week timepoint |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Fibromyalgia Impact Questionnaire-revised (FIQR) pain score | Fibromyalgia Impact Questionnaire-revised (FIQR) pain score is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). | Mean | Standard Deviation | score on a scale |
|
| Fibromyalgia Impact Questionnaire-revised (FIQR) total score | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. | Mean | Standard Deviation | units on a scale |
|
| EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). | Mean | Standard Deviation | units on a scale |
|
| Patient Reported Outcomes Measurement Information System (PROMIS) score for depression | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. | Mean | Standard Deviation | units on a scale |
|
| Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. | Mean | Standard Deviation | units on a scale |
|
| Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. | Mean | Standard Deviation | units on a scale |
|
| Multiple Ability Self-report Questionnaire (MASQ) score | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. | Mean | Standard Deviation | units on a scale |
|
|
| Primary | Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 12-week timepoint |
|
|
|
| Secondary | Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint | Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). | Posted | Mean | Standard Deviation | score on a scale | between baseline and 4-week timepoint |
|
|
|
| Secondary | Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 4-week timepoint |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) at 4-week Timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). | Posted | Mean | Standard Deviation | score on a scale | at 4-week timepoint |
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) at 12-week Timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). | Posted | Mean | Standard Deviation | score on a scale | at 12-week timepoint |
|
|
|
| Secondary | Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). | Posted | Mean | Standard Deviation | score on a scale | between baseline and 4-week timepoint |
|
|
|
| Secondary | Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). | Posted | Mean | Standard Deviation | score on a scale | between baseline and 12-week timepoint |
|
|
|
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 4-week timepoint |
|
|
|
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 12-week timepoint |
|
|
|
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 4-week timepoint |
|
|
|
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 12-week timepoint |
|
|
|
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 4-week timepoint |
|
|
|
| Secondary | Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 12-week timepoint |
|
|
|
| Secondary | Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 4-week timepoint |
|
|
|
| Secondary | Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. | Posted | Mean | Standard Deviation | score on a scale | between baseline and 12-week timepoint |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 40 |
| 50 |
|
| Nausea | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Neck pain | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Forehead pain during the session | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Persistence of sensation | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Sedative effect | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Skin reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Tooth pain | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Eye watering, tears | Nervous system disorders | Non-systematic Assessment | Expected side effect of the Cefaly® device |
|
| Shingles outbreak | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unexpected side effect of the Cefaly® device |
|
| Worsening fibromyalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unexpected side effect of the Cefaly® device |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment | Unexpected side effect of the Cefaly® device |
|
| Increase in sinus pain | Nervous system disorders | Non-systematic Assessment | Unexpected side effect of the Cefaly® device |
|
| Spacey feeling | Nervous system disorders | Non-systematic Assessment | Unexpected side effect of the Cefaly® device |
|
| Normal sensation of the Cefaly® device | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Including itching/tingling/stinging/twitching/vibration/numbness on forehead, scalp, eyes, eyelids, face, lips. But that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events. |
|
| Burning sensation on forehead or scalp, in eyelids or eyebrows | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Normal sensation of the Cefaly® device but that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events |
|
| Heaviness in eyelids | Nervous system disorders | Non-systematic Assessment | Normal sensation of the Cefaly® device but that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events |
|
| Forehead pressure | Nervous system disorders | Non-systematic Assessment | Normal sensation of the Cefaly® device but that did not result in treatment permanent discontinuation; these events should have not been considered as Adverse Events |
|
| Headache | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Sinus pressure | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Worsening IBS (Irritable Bowel Syndrome) | Renal and urinary disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Low back spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Flu infection, Cold virus infection, Sinus infection | Infections and infestations | Non-systematic Assessment | Relation to the device not suspected |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Back pain and stiffness | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Worsening fatigue | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Sebaceous cyst | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Gastrointestinal virus | Infections and infestations | Non-systematic Assessment | Relation to the device not suspected |
|
| Right knee injury | Surgical and medical procedures | Non-systematic Assessment | Relation to the device not suspected |
|
| Multiple joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Back strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Tubal ligation | Surgical and medical procedures | Non-systematic Assessment | Relation to the device not suspected |
|
| Increase in depression | Psychiatric disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Rash on ankles | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Vertigo | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Blurred vision | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Viral respiratory illness | Infections and infestations | Non-systematic Assessment | Relation to the device not suspected |
|
| Panic attack | Psychiatric disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Restlessness | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Worsening right knee or foot pain | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Swollen right thigh and knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Ringing in the ears/Ears ache | Ear and labyrinth disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Burning sensation in both legs and right shoulder | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Body tingling | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Relation to the device not suspected |
|
| Cold sensation in left cheek | Nervous system disorders | Non-systematic Assessment | Relation to the device not suspected |
|
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 45 days from the time submitted to the sponsor for review. Sponsor may request:
Sponsor's written consent is required for results communication before trial completion.
| D009422 |
| Nervous System Diseases |