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

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol required 3 subjects who were from the Cleveland Clinic migraine patient population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a one arm study

Reporting Groups
  Description
Deep Brain Stimulation Arm Group

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


Participant Flow:   Overall Study
    Deep Brain Stimulation Arm Group
STARTED   3 
COMPLETED   0 
NOT COMPLETED   3 
Infection and surgical explant                1 
Eligibility criteria expanded                1 
Stimulation response inadqequate                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
no subjects had data collected, 3 were enrolled, but did not have data collected or analyzed.

Reporting Groups
  Description
Deep Brain Stimulation Arm Group

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


Baseline Measures
   Deep Brain Stimulation Arm Group 
Overall Participants Analyzed 
[Units: Participants]
 0 
Age   
<=18 years   0 
Between 18 and 65 years   0 
>=65 years   0 
Race and Ethnicity Not Collected [1]    
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures

1.  Primary:   Migraine Relief at 2 Hours Post Stimulation   [ Time Frame: 8.5 Months ]

2.  Secondary:   Migraine Free at 2 Hours   [ Time Frame: 8.5 Months ]

3.  Secondary:   Pain Free at 2 Hours Post Stimulation   [ Time Frame: 8.5 months ]

4.  Secondary:   Acute Migraine Medication Use   [ Time Frame: 8.5 months ]

5.  Secondary:   Headache Impact Test (HIT-6) Compared With Baseline   [ Time Frame: 8.5 months ]

6.  Secondary:   Migraine Disability Assessment Scale (MIDAS) at Study Conclusion Compared With Baseline   [ Time Frame: 8.5 months ]

7.  Secondary:   Stimulation Related Adverse Events   [ Time Frame: 8.5 months ]

8.  Secondary:   Average Per Subject Reduction in Migraine Days/Month   [ Time Frame: 8.5 months ]

9.  Secondary:   Implantation and Stimulation Related Adverse Events   [ Time Frame: 8.5 months ]

10.  Secondary:   Relief of Migraine-associated Symptoms, e.g. Nausea/Vomiting, Photophobia, Phonophobia   [ Time Frame: 8.5 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: oconnok@ccf.org



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