Trial Outcomes & Findings for Peripheral Nerve Stimulation Registry for Intractable Migraine Headache (NCT NCT02227758)

NCT ID: NCT02227758

Last Updated: 2019-02-04

Results Overview

Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.

• Recruitment status: COMPLETED
• Target enrollment: 112 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-02-04

Participant Flow

Participant milestones

Measure	Implanted Chronic Migraine Patients Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system
Overall Study STARTED	112
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	67

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peripheral Nerve Stimulation Registry for Intractable Migraine Headache

Baseline characteristics by cohort

Measure	Implanted Chronic Migraine Patients n=112 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system
Age, Continuous	45.9 years n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment Sweden	1 participants n=5 Participants
Region of Enrollment Belgium	3 participants n=5 Participants
Region of Enrollment Luxembourg	1 participants n=5 Participants
Region of Enrollment United Kingdom	18 participants n=5 Participants
Region of Enrollment Germany	83 participants n=5 Participants
Region of Enrollment Spain	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.

Outcome measures

Measure	Implanted Chronic Migraine Patients n=112 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Adverse Events (First 12 Weeks) Hardware-related AE	17 events	—
Adverse Events (First 12 Weeks) Biological AE	27 events	—
Adverse Events (First 12 Weeks) Stimulation related AE	5 events	—
Adverse Events (First 12 Weeks) Other AE	1 events	—

PRIMARY outcome

Timeframe: 3 months

Population: 82 patients had available data for pain relief in the previous month at the 3 month follow-up visit

Patient reported headache pain relief in percentage for the previous month; patients were asked about their pain relief in percentage in the previous month; patient were asked "in the last month", how much headache relief has the implant provided (0% represents no relief, 100% represents complete relief)

Outcome measures

Measure	Implanted Chronic Migraine Patients n=82 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Headache Pain Relief	25.1 percentage pain relief Interval 0.0 to 100.0	—

PRIMARY outcome

Timeframe: 3 months

Population: 69 patients had available data for headache days in the previous 3 months at the 3 month follow-up visit

Percentage change in number of Headache days from Baseline to 3 Months. Headache days are the amount of days the subject had an headache in the previous 3 months as captured by the MIDAS questionnaire.

Outcome measures

Measure	Implanted Chronic Migraine Patients n=69 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Headache Days	-16 percent change in headache days Standard Deviation 0.71	—

PRIMARY outcome

Timeframe: 3 months

Population: 63 patients had available data for all 5 questions of the Midas questionnaire computing the total score at the 3 month follow-up visit. Excluding the outliers, 59 patients had available data.

Percentage change in Midas score from Baseline to 3 Months. The Midas questionnaire consists out of 5 questions to be answered by the patient. Three questions address the number of missed days due to headache in school or paid work, household work and family, social or leasure activities. The two remaining questions document the number of additional days with significant limitations to activity (defined as at least 50% reduced productivity) in the domains of employment and household work. The total score is the sum of days completed for questions 1-5. Midas score ranges from 0 to 21+ with higher values indicating greater disability.

Outcome measures

Measure	Implanted Chronic Migraine Patients n=63 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers n=59 Participants Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Migraine Disability	74 percentage of change Standard Deviation 6.2	-37 percentage of change Standard Deviation 0.4

PRIMARY outcome

Timeframe: 3 months

Population: 84 subjects had available data for patient satisfaction at the 3 month follow-up visit.

Patients very satisfied or satisfied with the headache relief since the implant. Patients were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)

Outcome measures

Measure	Implanted Chronic Migraine Patients n=84 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Patient Satisfaction	28 Participants	—

PRIMARY outcome

Timeframe: 3 months

Population: 84 subjects had available data for physician satisfaction at the 3 month follow-up visit.

Patients for who the physician is very satisfied or satisfied with the patient headache relief since the implant. Physicians were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)

Outcome measures

Measure	Implanted Chronic Migraine Patients n=84 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Physician Satisfaction	43 Participants	—

PRIMARY outcome

Timeframe: 3 months

Population: 83 subjects had available data for Quality of life at the 3 month follow-up visit.

Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)

Outcome measures

Measure	Implanted Chronic Migraine Patients n=83 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Quality of Life	32 Participants	—

PRIMARY outcome

Timeframe: 3 months

Population: 84 subjects had available data for physician reported overall quality of life

Patients for who the physician reported the change in overall quality of life of the patient since the implant with greatly improved or improved. Physicians were asked about the change in overall quality of life of the patient(Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)

Outcome measures

Measure	Implanted Chronic Migraine Patients n=84 Participants Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system	Midas Score Excluding 4 Outliers Excluding outliers with a reported increase of 128%,148%, 225%, 434%
Quality of Life	43 Participants	—

Adverse Events

Implanted Chronic Migraine Patients

Serious events: 26 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Implanted Chronic Migraine Patients n=112 participants at risk Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system who experienced a Serious Device related adverse event
Product Issues Breakage/facture of the extension	1.8% 2/112 • Number of events 2 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Product Issues Device Malfunction	1.8% 2/112 • Number of events 2 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Skin and subcutaneous tissue disorders IPG migration	1.8% 2/112 • Number of events 2 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Infections and infestations Infection: IPG and lead site	1.8% 2/112 • Number of events 2 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Infections and infestations Infection: lead site only	2.7% 3/112 • Number of events 3 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Product Issues Lead breakage/fracture	1.8% 2/112 • Number of events 2 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Skin and subcutaneous tissue disorders Lead migration	7.1% 8/112 • Number of events 8 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Skin and subcutaneous tissue disorders persistant pain and/or numbness: IPG site only	0.89% 1/112 • Number of events 1 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Skin and subcutaneous tissue disorders persistant pain and/or numbness: lead site only	0.89% 1/112 • Number of events 1 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Skin and subcutaneous tissue disorders persistent pain at connector site	0.89% 1/112 • Number of events 1 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Skin and subcutaneous tissue disorders skin erosion	1.8% 2/112 • Number of events 2 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%
Skin and subcutaneous tissue disorders Wound site complications	2.7% 3/112 • Number of events 3 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%

Other adverse events

Measure	Implanted Chronic Migraine Patients n=112 participants at risk Patients diagnosed with chronic migraine, failed 3 or more preventative drugs, with at least moderate disability, and implanted with a St. Jude Medical Conformité Européenne approved implantable neurostimulation system who experienced a Serious Device related adverse event
Surgical and medical procedures Persistent pain and/or numbness	6.2% 7/112 • Number of events 7 • 12 weeks Serious Device Related Adverse Events are described. The AE's reported on clinicaltrials.gov have a threshold of 5%

Additional Information

Clinical Study Director

St Jude Medical/Abbott

Email: rdiaz@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60