Ignite Creation Date:
2024-05-06 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03691272
Status:
COMPLETED
Last Update Posted:
2019-04-22
First Post:
2018-09-26
Brief Title:
rTMS Treatment of Persistent Headache and Post Concussion Symptoms Attributed to Mild Traumatic Injury to the Head
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Treatment of Persistent Headache Attributed to Mild Traumatic Injury to the Head PHATIH in Patients With Persistent Post Concussion Symptoms PPCS Using Repetitive Transcranial Magnetic Stimulation rTMS
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPiCS-rTMS
Brief Summary:
The objective of this study is to investigate the treatment effect of repetitive transcranial magnetic stimulation in patients with a history of both persistent post-traumatic headache and post-concussion symptoms In this double-blind sham-controlled concealed allocation randomized clinical trial 20 patients aged 18-65 yrs will be recruited from the Calgary Brain Injury Program CBIP and the Calgary Headache Assessment and Management Program CHAMP Calgary Chronic Pain Centre Calgary Alberta Canada Patients will engage in a two-week rTMS treatment protocol 10 treatments and will be followed for 6 months after therapy
Detailed Description:
Demographic information will be collected two weeks prior to starting the study including age sex education headache history concussion history past medical history medication use and family medical history Headache history will be collected including frequency severity medication-use type of headache associated symptoms ie neck pain photophobia phonophobia nausea vomiting and headache triggers Baseline questionnaires will be completed including headache intensity scale - 6 HIT-6 Rivermead PPCS questionnaire British Columbia post-concussion symptom inventory BC-PSI Montreal cognitive assessment MoCA quality of life after brain injury questionnaire QOLIBRI patient health questionnaire-9 PHQ-9 generalized anxiety disorder scale-7 GADS-7 and the post traumatic stress disorder checklist for DSM-5 PCL-5 Patients will keep a two-week baseline headache diary before treatment 2 weeks during treatment 2 weeks following rTMS and for 2 weeks at the 1 3 and 6 month follow up assessments total of 12 weeks Patients will be reassessed at the completion of their rTMS treatment day 14 and at 1 3 and 6 months post-treatment The questionnaires including HIT-6 Rivermead PPCS questionnaire PC-PSI QOLIBRI PHQ-9 and GAD-7 will be completed at all follow up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None