ClinicalTrials.gov
ClinicalTrials.gov Menu

Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

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: NCT01294046
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : March 7, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Autonomic Technologies, Inc.
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Headache
Intervention Device: Deep Brain Stimulation of SPG for Migraine
Enrollment 3

Recruitment Details Protocol required 3 subjects who were from the Cleveland Clinic migraine patient population.
Pre-assignment Details This is a one arm study
Arm/Group Title Deep Brain Stimulation Arm Group
Hide Arm/Group Description

Electrical Stimulation of SPG for Treatment of Migraine

Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Reason Not Completed
Infection and surgical explant             1
Eligibility criteria expanded             1
Stimulation response inadqequate             1
Arm/Group Title Deep Brain Stimulation Arm Group
Hide Arm/Group Description

Electrical Stimulation of SPG for Treatment of Migraine

Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
no subjects had data collected, 3 were enrolled, but did not have data collected or analyzed.
Age, Categorical  
Number Analyzed 0 participants
<=18 years 0
Between 18 and 65 years 0
>=65 years 0
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Race and Ethnicity Not Collected   [1] 
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title Migraine Relief at 2 Hours Post Stimulation
Hide Description Pain is rated at stimulation and 2 hours after stimulation initiated based on four point categorical scale, FDA-approved, where 0 = no headache pain, 1= mild pain, 2 = moderate pain, 3 = severe pain. This scale has been used since 1991 for all regulatory submission migraine protocols. Each migraine is categorized in a binary fashion as meeting the endpoint at 2 hours. Migraine relief or Pain relief is defined as moving from pain levels of 3 to 2 down to 1 or 0.
Time Frame 8.5 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation Arm Group
Hide Arm/Group Description:

Electrical Stimulation of SPG for Treatment of Migraine

Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Migraine Free at 2 Hours
Hide Description Each migraine will be categorized as meeting the endpoint of migraine free if there is a reduction in the migraine grade to 0 for pain with no nausea, photophobia and phonophobia at 2 hours after initiation of stimulation.
Time Frame 8.5 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation Arm Group
Hide Arm/Group Description:

Electrical Stimulation of SPG for Treatment of Migraine

Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Pain Free at 2 Hours Post Stimulation
Hide Description As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Experimental: Deep Brain Stimulation Arm Group
Hide Arm/Group Description:

Experimental: Deep brain stimulation arm group

Electrical Stimulation of SPG for Treatment of Migraine

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Acute Migraine Medication Use
Hide Description During the baseline period, subjects will record their acute as-needed migraine relief medication use for each attack by drug, dose, route, and frequency. A secondary endpoint for this phase is a reduction in acute migraine medication usage for each attack for drug, dose, route, and frequency during the last month of the study as compared to the baseline month.
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation of SPG for Migraine
Hide Arm/Group Description:

Electrical SPG for Treatment of Migraine

Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine

No outcome measure data was analyzed because no outcome data were collected.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Headache Impact Test (HIT-6) Compared With Baseline
Hide Description The Headache Impact Test -6 (HIT-6) is a validated tool for evaluating headache impact and disability across 6 domains, which will be recorded at baseline and at study conclusion.
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation Arm Group
Hide Arm/Group Description:

Electrical Stimulation of SPG for Treatment of Migraine

Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline
Hide Description The Migraine Disability Assessment Scale (MIDAS) is a validated tool that assesses how many days in the last 3 months a patient had at least 50% disability at work, home, school, or recreational activities due to migraine. MIDAS will be assessed at baseline and after study conclusion.
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation of SPG for Migraine
Hide Arm/Group Description:

Electrical SPG for Treatment of Migraine

Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine

No data were collected from this entire study, so no data were analyzed.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Stimulation Related Adverse Events
Hide Description Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation of SPG for Migraine
Hide Arm/Group Description:

Electrical SPG for Treatment of Migraine

Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine

No data were collected from this entire study, so no data were analyzed.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Average Per Subject Reduction in Migraine Days/Month
Hide Description During the baseline period, subjects will record the number of migraine days (as defined by the FDA-approved International Classification of Headache Disorders, 2d Edition definition of migraine with and without aura) during the month. The primary endpoint for this phase is a reduction in the number of migraine days during the last month of the study as compared to the baseline month.
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation of SPG for Migraine
Hide Arm/Group Description:

Electrical SPG for Treatment of Migraine

Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine

No data were collected from this entire study, so no data were analyzed.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Implantation and Stimulation Related Adverse Events
Hide Description As noted above, we are using the FDA-approved categorical scale used for all migraine regulatory trials since 1992. This is a 4 point categorical scale where 0= no pain, 1= mild headache pain, 2= moderate pain, and 3= severe pain. Pain free is defined as the subject moving from pain intensity of 2 to 3 at baseine to 0 by 2 hours after stimulation.
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation of SPG for Migraine
Hide Arm/Group Description:

Electrical SPG for Treatment of Migraine

Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine

No data were collected from this entire study, so no data were analyzed.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia
Hide Description Presence or absence of nausea, vomiting, photophobia, and phonophobia will be assessed at baseline and after stimulation at 2 hours for each stimulation for each individual.
Time Frame 8.5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from this entire study, so no data were analyzed.
Arm/Group Title Deep Brain Stimulation of SPG for Migraine
Hide Arm/Group Description:

Electrical SPG for Treatment of Migraine

Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine

No data were collected from this entire study, so no data were analyzed.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 month, the time between implant and explant which was performed due to subject infection. No treatment period occurred.
Adverse Event Reporting Description

There was one adverse event which was an infection which required the explant surgery. Full report was made to the FDA and the IRB of this adverse event.

The other two subjects who were consented and enrolled did not receive any treatment and no adverse events were noted.

 
Arm/Group Title Deep Brain Stimulation Arm Group
Hide Arm/Group Description

Electrical Stimulation of SPG for Treatment of Migraine

Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches

All-Cause Mortality
Deep Brain Stimulation Arm Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Deep Brain Stimulation Arm Group
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Nervous system disorders   
Infection and surgical explant * [1]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Infection and surgical explant
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Deep Brain Stimulation Arm Group
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kathryn O'Connor
Organization: Cleveland Clinic
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01294046     History of Changes
Other Study ID Numbers: IDE Number : G100007
First Submitted: February 4, 2011
First Posted: February 11, 2011
Results First Submitted: January 18, 2017
Results First Posted: March 7, 2017
Last Update Posted: April 14, 2017