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Treatment for Migraines With an Implantable Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286078
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : August 9, 2016
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine
Intervention Device: Precision
Enrollment 179
Recruitment Details  
Pre-assignment Details 179 subjects signed consent, 39 subjects screen failed, and 140 eligible subjects were randomized (1 subject was later excluded).
Arm/Group Title Treatment Control
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Active occipital nerve stimulation (stimulation on).

Precision: Implantable neurostimulator

Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.
Period Title: Overall Study
Started 72 68
12 Weeks 63 62
Completed 40 34
Not Completed 32 34
Arm/Group Title Treatment Control Total
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Stimulation on

Precision: Implantable neurostimulator

Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.

Precision: Implantable neurostimulator

Total of all reporting groups
Overall Number of Baseline Participants 71 68 139
Hide Baseline Analysis Population Description
1 subject excluded from analysis because HIPAA authorization was not obtained; randomized to active group, received percutaneous trial only
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 68 participants 139 participants
41.5  (11.2) 43.8  (11.9) 42.6  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 68 participants 139 participants
Female
60
  84.5%
57
  83.8%
117
  84.2%
Male
11
  15.5%
11
  16.2%
22
  15.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 71 participants 68 participants 139 participants
71 68 139
1.Primary Outcome
Title Migraine Frequency at 12 Weeks
Hide Description Change from baseline in migraine days/month at 12 weeks
Time Frame Baseline and 12 weeks
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Modified Intent to Treat
Arm/Group Title Treatment Control
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Stimulation on

Precision: Implantable neurostimulator

Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.

Precision: Implantable neurostimulator

Overall Number of Participants Analyzed 63 62
Mean (Standard Deviation)
Unit of Measure: days
-5.5  (8.7) -3.9  (8.2)
2.Primary Outcome
Title Frequency of Adverse Event
Hide Description Cumulative frequency of adverse events from randomization to 26 weeks
Time Frame 26 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Stimulation on

Precision: Implantable neurostimulator

Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.

Precision: Implantable neurostimulator

Overall Number of Participants Analyzed 71 68
Measure Type: Number
Unit of Measure: events
276 284
Time Frame Safety data was collected through the 12 year follow up visit.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control
Hide Arm/Group Description

Active occipital nerve stimulation (stimulation on)

Precision: Implantable neurostimulator

Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.

Precision: Implantable neurostimulator

All-Cause Mortality
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/72 (45.83%)      19/68 (27.94%)    
Blood and lymphatic system disorders     
Anaemia  1/72 (1.39%)  1 0/68 (0.00%)  0
Cardiac disorders     
Bradycardia  1/72 (1.39%)  1 0/68 (0.00%)  0
Cardiac Failure Congestive  1/72 (1.39%)  1 0/68 (0.00%)  0
Congestive Cardiomyopathy  1/72 (1.39%)  1 0/68 (0.00%)  0
Myocardial Infarction  1/72 (1.39%)  1 1/68 (1.47%)  1
Congenital, familial and genetic disorders     
Arnold-Chiari Malformation  1/72 (1.39%)  1 0/68 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain Upper  0/72 (0.00%)  0 1/68 (1.47%)  1
Constipation  1/72 (1.39%)  1 0/68 (0.00%)  0
Gastrointestinal Haemorrhage  1/72 (1.39%)  1 0/68 (0.00%)  0
Haemorrhoids  1/72 (1.39%)  1 0/68 (0.00%)  0
Pancreatitis  1/72 (1.39%)  1 0/68 (0.00%)  0
General disorders     
Adverse Drug Reaction  0/72 (0.00%)  0 1/68 (1.47%)  1
Death  1/72 (1.39%)  1 0/68 (0.00%)  0
Oedema Peripheral  1/72 (1.39%)  1 0/68 (0.00%)  0
Pyrexia  1/72 (1.39%)  1 0/68 (0.00%)  0
Hepatobiliary disorders     
Cholangitis  1/72 (1.39%)  1 0/68 (0.00%)  0
Cholecystitis  1/72 (1.39%)  1 0/68 (0.00%)  0
Cholelithiasis  1/72 (1.39%)  1 0/68 (0.00%)  0
Infections and infestations     
Bacterial Infection  0/72 (0.00%)  0 1/68 (1.47%)  1
Device related infection  1/72 (1.39%)  2 2/68 (2.94%)  2
Wound infection  0/72 (0.00%)  0 1/68 (1.47%)  1
Abscess Limb  0/72 (0.00%)  0 1/68 (1.47%)  1
Appendicitis  0/72 (0.00%)  0 1/68 (1.47%)  1
Bacterial Sepsis  1/72 (1.39%)  1 0/68 (0.00%)  0
Cellulitis  1/72 (1.39%)  2 1/68 (1.47%)  1
Endocarditis  1/72 (1.39%)  1 0/68 (0.00%)  0
Implant Site Infection  1/72 (1.39%)  1 0/68 (0.00%)  0
Osteomyelitis  0/72 (0.00%)  0 1/68 (1.47%)  1
Pneumonia  0/72 (0.00%)  0 1/68 (1.47%)  1
Septic Embolus  1/72 (1.39%)  1 0/68 (0.00%)  0
Stitch Abscess  1/72 (1.39%)  1 0/68 (0.00%)  0
Viral Infection  0/72 (0.00%)  0 1/68 (1.47%)  1
Injury, poisoning and procedural complications     
Wrist fracture  0/72 (0.00%)  0 1/68 (1.47%)  1
Device Lead Damage  1/72 (1.39%)  1 0/68 (0.00%)  0
Drug Toxicity  2/72 (2.78%)  2 0/68 (0.00%)  0
Lower Limb Fracture  1/72 (1.39%)  1 0/68 (0.00%)  0
Pelvic Fracture  1/72 (1.39%)  1 0/68 (0.00%)  0
Post Lumbar Puncture Syndrome  1/72 (1.39%)  1 0/68 (0.00%)  0
Road Traffic Accident  1/72 (1.39%)  1 0/68 (0.00%)  0
Therapeutic Agent Toxicity  1/72 (1.39%)  2 0/68 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1/72 (1.39%)  1 0/68 (0.00%)  0
Intervertebral Disc Protusion  1/72 (1.39%)  5 0/68 (0.00%)  0
Tendonitis  1/72 (1.39%)  1 0/68 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer  1/72 (1.39%)  1 0/68 (0.00%)  0
Nervous system disorders     
Migraine  6/72 (8.33%)  7 2/68 (2.94%)  3
Cerebral Infarction  1/72 (1.39%)  1 0/68 (0.00%)  0
Cerebrovascular Accident  1/72 (1.39%)  1 0/68 (0.00%)  0
Encephalopathy  1/72 (1.39%)  1 0/68 (0.00%)  0
Headache  3/72 (4.17%)  3 0/68 (0.00%)  0
Intracranial Venous Sinus Thrombosis  1/72 (1.39%)  1 0/68 (0.00%)  0
Migraine without Aura  1/72 (1.39%)  1 1/68 (1.47%)  1
Syncope  1/72 (1.39%)  1 1/68 (1.47%)  1
Trigeminal Neuralgia  0/72 (0.00%)  0 1/68 (1.47%)  1
Psychiatric disorders     
Mental status changes  1/72 (1.39%)  1 0/68 (0.00%)  0
Suicidal ideation  1/72 (1.39%)  1 0/68 (0.00%)  0
Suicide attempt  0/72 (0.00%)  0 1/68 (1.47%)  1
Completed Suicide  1/72 (1.39%)  1 0/68 (0.00%)  0
Conversion Disorder  1/72 (1.39%)  1 0/68 (0.00%)  0
Depression  1/72 (1.39%)  1 0/68 (0.00%)  0
Major Depression  1/72 (1.39%)  1 0/68 (0.00%)  0
Psychotic Disorder  0/72 (0.00%)  0 1/68 (1.47%)  1
Renal and urinary disorders     
Nephrolithiasis  1/72 (1.39%)  1 0/68 (0.00%)  0
Renal Tubular Necrosis  0/72 (0.00%)  0 1/68 (1.47%)  1
Urinary Tract Obstruction  1/72 (1.39%)  1 0/68 (0.00%)  0
Reproductive system and breast disorders     
Menorrhagia  1/72 (1.39%)  1 0/68 (0.00%)  0
Cystocele  0/72 (0.00%)  0 1/68 (1.47%)  1
Endometriosis  1/72 (1.39%)  1 0/68 (0.00%)  0
Ovarian Cyst  0/72 (0.00%)  0 1/68 (1.47%)  1
Rectocele  0/72 (0.00%)  0 1/68 (1.47%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory arrest  0/72 (0.00%)  0 1/68 (1.47%)  1
Respiratory Failure  1/72 (1.39%)  1 0/68 (0.00%)  0
Sleep Apnoea Syndrome  1/72 (1.39%)  2 0/68 (0.00%)  0
Vascular disorders     
Hypotension  2/72 (2.78%)  2 0/68 (0.00%)  0
Subclavian Vein Thrombosis  1/72 (1.39%)  1 0/68 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/72 (94.44%)      63/68 (92.65%)    
Gastrointestinal disorders     
Nausea  16/72 (22.22%)  18 9/68 (13.24%)  12
Vomiting  6/72 (8.33%)  7 2/68 (2.94%)  3
General disorders     
Implant site pain  10/72 (13.89%)  14 16/68 (23.53%)  17
Therapeutic product ineffective  46/72 (63.89%)  67 44/68 (64.71%)  66
Oedema Peripheral  4/72 (5.56%)  4 2/68 (2.94%)  2
Infections and infestations     
Bronchitis  3/72 (4.17%)  3 6/68 (8.82%)  6
Nasopharyngitis  7/72 (9.72%)  8 5/68 (7.35%)  5
Sinusitis  7/72 (9.72%)  9 10/68 (14.71%)  17
Injury, poisoning and procedural complications     
Inappropriate device stimulation of tissue  24/72 (33.33%)  30 9/68 (13.24%)  10
Incision site complication  3/72 (4.17%)  3 5/68 (7.35%)  5
Incision site pain  5/72 (6.94%)  5 8/68 (11.76%)  9
Medical device pain  4/72 (5.56%)  4 7/68 (10.29%)  9
Device Migration  4/72 (5.56%)  4 4/68 (5.88%)  6
Medical device complication  5/72 (6.94%)  8 2/68 (2.94%)  3
Musculoskeletal and connective tissue disorders     
Back pain  8/72 (11.11%)  9 8/68 (11.76%)  10
Muscle spasms  1/72 (1.39%)  1 8/68 (11.76%)  9
Musculoskeletal stiffness  3/72 (4.17%)  3 4/68 (5.88%)  4
Neck pain  6/72 (8.33%)  7 10/68 (14.71%)  10
Musculoskeletal pain  2/72 (2.78%)  4 4/68 (5.88%)  4
Myalgia  5/72 (6.94%)  5 1/68 (1.47%)  1
Nervous system disorders     
Headache  14/72 (19.44%)  22 9/68 (13.24%)  14
Migraine  6/72 (8.33%)  12 11/68 (16.18%)  13
Paresthesia  6/72 (8.33%)  6 3/68 (4.41%)  3
Tremor  1/72 (1.39%)  1 4/68 (5.88%)  5
Psychiatric disorders     
Insomnia  7/72 (9.72%)  7 4/68 (5.88%)  4
Depression  1/72 (1.39%)  1 4/68 (5.88%)  5
Insomnia  7/72 (9.72%)  8 6/68 (8.82%)  7
Vascular disorders     
Hypertension  3/72 (4.17%)  3 4/68 (5.88%)  4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Information
Organization: Boston Scientific
Phone: 855-213-9890
EMail: BSNClinicalTrials@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00286078    
Other Study ID Numbers: EI0105
First Submitted: February 1, 2006
First Posted: February 3, 2006
Results First Submitted: April 6, 2016
Results First Posted: August 9, 2016
Last Update Posted: July 30, 2019