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Treatment for Migraines With an Implantable Device

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ClinicalTrials.gov Identifier: NCT00286078
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : August 9, 2016
Last Update Posted : January 1, 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.
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

Period Title: Overall Study
Started 72 68
12 Weeks 63 62
Completed 40 34
Not Completed 32 34
Arm/Group Title Treatment Control Total
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

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat
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 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
Show Outcome Measure DataHide Outcome Measure Data
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 [Not Specified]
Adverse Event Reporting 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

All-Cause Mortality
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/71 (7.04%)      7/68 (10.29%)    
Gastrointestinal disorders     
Lip Swelling  0/71 (0.00%)  0 1/68 (1.47%)  1
Infections and infestations     
Bacterial Infection  0/71 (0.00%)  0 1/68 (1.47%)  2
Device related infection  0/71 (0.00%)  0 1/68 (1.47%)  1
Pseudomonas infection  1/71 (1.41%)  1 0/68 (0.00%)  0
Wound infection  1/71 (1.41%)  1 0/68 (0.00%)  0
Injury, poisoning and procedural complications     
Wrist fracture  0/71 (0.00%)  0 1/68 (1.47%)  2
Nervous system disorders     
Migraine  1/71 (1.41%)  1 1/68 (1.47%)  2
Psychiatric disorders     
Mental status changes  1/71 (1.41%)  2 0/68 (0.00%)  0
Suicidal ideation  1/71 (1.41%)  1 0/68 (0.00%)  0
Suicide attempt  0/71 (0.00%)  0 1/68 (1.47%)  1
Reproductive system and breast disorders     
Menorrhagia  1/71 (1.41%)  1 0/68 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory arrest  0/71 (0.00%)  0 1/68 (1.47%)  1
Surgical and medical procedures     
Drug detoxification  1/71 (1.41%)  1 0/68 (0.00%)  0
Show Other (Not Including Serious) Adverse Events 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   68/71 (95.77%)      63/68 (92.65%)    
Gastrointestinal disorders     
Nausea  8/71 (11.27%)  10 6/68 (8.82%)  6
Vomiting  6/71 (8.45%)  7 2/68 (2.94%)  2
General disorders     
Implant site pain  6/71 (8.45%)  8 10/68 (14.71%)  12
Therapeutic product ineffective  25/71 (35.21%)  28 20/68 (29.41%)  22
Infections and infestations     
Bronchitis  3/71 (4.23%)  3 4/68 (5.88%)  4
Nasopharyngitis  5/71 (7.04%)  5 2/68 (2.94%)  2
Sinusitis  7/71 (9.86%)  7 7/68 (10.29%)  7
Injury, poisoning and procedural complications     
Inappropriate device stimulation of tissue  16/71 (22.54%)  18 5/68 (7.35%)  6
Incision site complication  4/71 (5.63%)  4 7/68 (10.29%)  8
Incision site pain  3/71 (4.23%)  3 7/68 (10.29%)  8
Medical device pain  3/71 (4.23%)  3 5/68 (7.35%)  6
Musculoskeletal and connective tissue disorders     
Back pain  3/71 (4.23%)  3 6/68 (8.82%)  7
Muscle spasms  0/71 (0.00%)  0 4/68 (5.88%)  4
Musculoskeletal stiffness  3/71 (4.23%)  3 4/68 (5.88%)  4
Neck pain  2/71 (2.82%)  2 6/68 (8.82%)  6
Nervous system disorders     
Headache  11/71 (15.49%)  12 7/68 (10.29%)  7
Migraine  6/71 (8.45%)  10 7/68 (10.29%)  9
Psychiatric disorders     
Insomnia  7/71 (9.86%)  7 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
Name/Title: Clinical Research Information
Organization: Boston Scientific
Phone: 855-213-9890
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00286078     History of Changes
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: January 1, 2019