Trial Outcomes & Findings for Treatment for Migraines With an Implantable Device (NCT NCT00286078)
NCT ID: NCT00286078
Last Updated: 2019-07-30
Results Overview
Change from baseline in migraine days/month at 12 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
179 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2019-07-30
Participant Flow
179 subjects signed consent, 39 subjects screen failed, and 140 eligible subjects were randomized (1 subject was later excluded).
Participant milestones
| Measure |
Treatment
Active occipital nerve stimulation (stimulation on).
Precision: Implantable neurostimulator
|
Control
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
68
|
|
Overall Study
12 Weeks
|
63
|
62
|
|
Overall Study
COMPLETED
|
40
|
34
|
|
Overall Study
NOT COMPLETED
|
32
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for Migraines With an Implantable Device
Baseline characteristics by cohort
| Measure |
Treatment
n=71 Participants
Stimulation on
Precision: Implantable neurostimulator
|
Control
n=68 Participants
Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
43.8 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
42.6 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
71 participants
n=99 Participants
|
68 participants
n=107 Participants
|
139 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: Modified Intent to Treat
Change from baseline in migraine days/month at 12 weeks
Outcome measures
| Measure |
Treatment
n=63 Participants
Stimulation on
Precision: Implantable neurostimulator
|
Control
n=62 Participants
Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator
|
|---|---|---|
|
Migraine Frequency at 12 Weeks
|
-5.5 days
Standard Deviation 8.7
|
-3.9 days
Standard Deviation 8.2
|
PRIMARY outcome
Timeframe: 26 weeksCumulative frequency of adverse events from randomization to 26 weeks
Outcome measures
| Measure |
Treatment
n=71 Participants
Stimulation on
Precision: Implantable neurostimulator
|
Control
n=68 Participants
Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator
|
|---|---|---|
|
Frequency of Adverse Event
|
276 events
|
284 events
|
Adverse Events
Treatment
Serious events: 33 serious events
Other events: 68 other events
Deaths: 0 deaths
Control
Serious events: 19 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=72 participants at risk
Active occipital nerve stimulation (stimulation on)
Precision: Implantable neurostimulator
|
Control
n=68 participants at risk
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator
|
|---|---|---|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Device related infection
|
1.4%
1/72 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
2.9%
2/68 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Wound infection
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Migraine
|
8.3%
6/72 • Number of events 7 • Safety data was collected through the 12 year follow up visit.
|
2.9%
2/68 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Mental status changes
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Cardiac disorders
Bradycardia
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
General disorders
Death
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
General disorders
Oedema Peripheral
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
General disorders
Pyrexia
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Hepatobiliary disorders
Cholangitis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Bacterial Sepsis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/72 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Endocarditis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Implant Site Infection
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Septic Embolus
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Stitch Abscess
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Device Lead Damage
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Drug Toxicity
|
2.8%
2/72 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
1.4%
1/72 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protusion
|
1.4%
1/72 • Number of events 5 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Cerebral Infarction
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Headache
|
4.2%
3/72 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Intracranial Venous Sinus Thrombosis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Migraine without Aura
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Syncope
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Completed Suicide
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Conversion Disorder
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Depression
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Major Depression
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Reproductive system and breast disorders
Endometriosis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/72 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
1.4%
1/72 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Vascular disorders
Hypotension
|
2.8%
2/72 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
|
Congenital, familial and genetic disorders
Arnold-Chiari Malformation
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
0.00%
0/68 • Safety data was collected through the 12 year follow up visit.
|
Other adverse events
| Measure |
Treatment
n=72 participants at risk
Active occipital nerve stimulation (stimulation on)
Precision: Implantable neurostimulator
|
Control
n=68 participants at risk
Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
Precision: Implantable neurostimulator
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
22.2%
16/72 • Number of events 18 • Safety data was collected through the 12 year follow up visit.
|
13.2%
9/68 • Number of events 12 • Safety data was collected through the 12 year follow up visit.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
6/72 • Number of events 7 • Safety data was collected through the 12 year follow up visit.
|
2.9%
2/68 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
|
General disorders
Implant site pain
|
13.9%
10/72 • Number of events 14 • Safety data was collected through the 12 year follow up visit.
|
23.5%
16/68 • Number of events 17 • Safety data was collected through the 12 year follow up visit.
|
|
General disorders
Therapeutic product ineffective
|
63.9%
46/72 • Number of events 67 • Safety data was collected through the 12 year follow up visit.
|
64.7%
44/68 • Number of events 66 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Bronchitis
|
4.2%
3/72 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
8.8%
6/68 • Number of events 6 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Nasopharyngitis
|
9.7%
7/72 • Number of events 8 • Safety data was collected through the 12 year follow up visit.
|
7.4%
5/68 • Number of events 5 • Safety data was collected through the 12 year follow up visit.
|
|
Infections and infestations
Sinusitis
|
9.7%
7/72 • Number of events 9 • Safety data was collected through the 12 year follow up visit.
|
14.7%
10/68 • Number of events 17 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Inappropriate device stimulation of tissue
|
33.3%
24/72 • Number of events 30 • Safety data was collected through the 12 year follow up visit.
|
13.2%
9/68 • Number of events 10 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
4.2%
3/72 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
7.4%
5/68 • Number of events 5 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
6.9%
5/72 • Number of events 5 • Safety data was collected through the 12 year follow up visit.
|
11.8%
8/68 • Number of events 9 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Medical device pain
|
5.6%
4/72 • Number of events 4 • Safety data was collected through the 12 year follow up visit.
|
10.3%
7/68 • Number of events 9 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
8/72 • Number of events 9 • Safety data was collected through the 12 year follow up visit.
|
11.8%
8/68 • Number of events 10 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
11.8%
8/68 • Number of events 9 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
4.2%
3/72 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
5.9%
4/68 • Number of events 4 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
6/72 • Number of events 7 • Safety data was collected through the 12 year follow up visit.
|
14.7%
10/68 • Number of events 10 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Headache
|
19.4%
14/72 • Number of events 22 • Safety data was collected through the 12 year follow up visit.
|
13.2%
9/68 • Number of events 14 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Migraine
|
8.3%
6/72 • Number of events 12 • Safety data was collected through the 12 year follow up visit.
|
16.2%
11/68 • Number of events 13 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Insomnia
|
9.7%
7/72 • Number of events 8 • Safety data was collected through the 12 year follow up visit.
|
8.8%
6/68 • Number of events 7 • Safety data was collected through the 12 year follow up visit.
|
|
General disorders
Oedema Peripheral
|
5.6%
4/72 • Number of events 4 • Safety data was collected through the 12 year follow up visit.
|
2.9%
2/68 • Number of events 2 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Device Migration
|
5.6%
4/72 • Number of events 4 • Safety data was collected through the 12 year follow up visit.
|
5.9%
4/68 • Number of events 6 • Safety data was collected through the 12 year follow up visit.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
6.9%
5/72 • Number of events 8 • Safety data was collected through the 12 year follow up visit.
|
2.9%
2/68 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.8%
2/72 • Number of events 4 • Safety data was collected through the 12 year follow up visit.
|
5.9%
4/68 • Number of events 4 • Safety data was collected through the 12 year follow up visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
5/72 • Number of events 5 • Safety data was collected through the 12 year follow up visit.
|
1.5%
1/68 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Paresthesia
|
8.3%
6/72 • Number of events 6 • Safety data was collected through the 12 year follow up visit.
|
4.4%
3/68 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
|
Nervous system disorders
Tremor
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
5.9%
4/68 • Number of events 5 • Safety data was collected through the 12 year follow up visit.
|
|
Psychiatric disorders
Depression
|
1.4%
1/72 • Number of events 1 • Safety data was collected through the 12 year follow up visit.
|
5.9%
4/68 • Number of events 5 • Safety data was collected through the 12 year follow up visit.
|
|
Vascular disorders
Hypertension
|
4.2%
3/72 • Number of events 3 • Safety data was collected through the 12 year follow up visit.
|
5.9%
4/68 • Number of events 4 • Safety data was collected through the 12 year follow up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place