Trial Outcomes & Findings for Study of Occipital Nerve Stimulation for Drug Refractory Migraine (NCT NCT00747812)
NCT ID: NCT00747812
Last Updated: 2020-11-27
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-11-27
Participant Flow
Participant milestones
| Measure |
Active Stimulation (Treatment Group)
Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
|
Sham Stimulation (Control Group)
Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Active Stimulation (Treatment Group)
Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
|
Sham Stimulation (Control Group)
Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
|
|---|---|---|
|
Overall Study
Research Site Staff Relocation
|
5
|
3
|
Baseline Characteristics
Study of Occipital Nerve Stimulation for Drug Refractory Migraine
Baseline characteristics by cohort
| Measure |
Active Stimulation (Treatment Group)
n=5 Participants
Stimulation on from activation to 12 weeks post-activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
|
Sham Stimulation (Control Group)
n=3 Participants
Sham Stimulation from activation of device to 12 weeks post-activation. Stimulation on from 12 weeks post-activation on.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Active Stimulation (Treatment Group)
n=5 Participants
Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
|
Sham Stimulation (Control Group)
n=3 Participants
Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
|
|---|---|---|
|
Number of Hours of Headache
|
NA Hours
Standard Deviation NA
Efficacy endpoint data for this study was not analyzed because of the amount of insufficient data collected from the limited number of implanted subjects.
|
NA Hours
Standard Deviation NA
Efficacy endpoint data for this study was not analyzed because of the amount of insufficient data collected from the limited number of implanted subjects.
|
PRIMARY outcome
Timeframe: 12 WeeksOutcome measures
| Measure |
Active Stimulation (Treatment Group)
n=5 Participants
Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
|
Sham Stimulation (Control Group)
n=3 Participants
Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
|
|---|---|---|
|
Number of Days With 4 or More Hours of Headache
|
NA Days
Standard Deviation NA
Efficacy endpoint data for this study was not analyzed because of the amount of insufficient data collected from the limited number of implanted subjects.
|
NA Days
Standard Deviation NA
Efficacy endpoint data for this study was not analyzed because of the amount of insufficient data collected from the limited number of implanted subjects.
|
Adverse Events
Active Stimulation (Treatment Group)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham Stimulation (Control Group)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Stimulation (Treatment Group)
n=5 participants at risk
Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
|
Sham Stimulation (Control Group)
n=4 participants at risk
Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
|
|---|---|---|
|
Renal and urinary disorders
Proteinuria
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Therapeutic Product Ineffective
|
40.0%
2/5 • Number of events 2
|
0.00%
0/4
|
|
General disorders
Implant Site Pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Device Ineffective
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Active Stimulation (Treatment Group)
n=5 participants at risk
Active stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation off from 12 weeks post-activation to 16 weeks post-activation. Stimulation on from 16 weeks post-activation to end of study.
|
Sham Stimulation (Control Group)
n=4 participants at risk
Sham stimulation from IPG activation to 12 weeks post-IPG activation. Stimulation on from 12 weeks post-activation on.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Number of events 2
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
40.0%
2/5 • Number of events 2
|
75.0%
3/4 • Number of events 3
|
|
Gastrointestinal disorders
Toothache
|
40.0%
2/5 • Number of events 2
|
0.00%
0/4
|
|
General disorders
Fatigue
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Impaired healing
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Implant site pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Implant site reaction
|
40.0%
2/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Inflammation
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Implant site infection
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Incision site infection
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Infections and infestations
Wound infection
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Gastrointestinal disorder postoperative
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Inappropriate device stimulation of tissue
|
60.0%
3/5 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site complication
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Incision site pain
|
80.0%
4/5 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medical device pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound complication
|
20.0%
1/5 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound secretion
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Investigations
Weight decreased
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
40.0%
2/5 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
60.0%
3/5 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Dysaesthesia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
50.0%
2/4 • Number of events 2
|
|
Nervous system disorders
Syncope vasovagal
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Sleep disorder
|
40.0%
2/5 • Number of events 2
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/5
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
2/5 • Number of events 2
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
|
Vascular disorders
Orthostatic hypotension
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Additional Information
Lyn Pimentel, Clinical Project Manager
Boston Scientific
Phone: (661) 949-4174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place