CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
rTMS - Real Air Film Coil +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03691272
NCT03691272Phase 2Completed
CompareCT.gov

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)

University of Calgary·interventional·Posted Oct 1, 2018·Updated Apr 22, 2019

In Brief

A Phase 2 clinical trial evaluating rTMS - Real Air Film Coil and rTMS - Sham Coil for Brain Injuries, Traumatic and 6 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Injuries, Traumatic, Concussion, Brain, Headaches Chronic, Headache, Post-Traumatic Headache, Mild Traumatic Brain Injury, Transcranial Magnetic Stimulation
CountriesCanada
CollaboratorsHotchkiss Brain Institute, University of Calgary

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 1, 2018
Enrollment StartApr 15, 2017
Primary CompletionSep 30, 2018
Study CompletionJan 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.8 years ago

Interventions

rTMS - Real Air Film Coildevice

70% resting motor threshold amplitude; Frequency 10 Hz; 10 trains of 60 pulses/train (total of 600 pulses); Inter-train interval 45s.

rTMS - Sham Coildevice

A sham coil will be applied to the scalp after the resting motor threshold is determined. Patients will be able to hear the sound and feel the vibration of sham coil, but will not experience any effective stimulation.