Improving Functions in MTBI Patients With Headache by rTMS

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Improving Functions in MTBI Patients With Headache by rTMS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948947
• Other study ID #: F1359-P
• Secondary ID: H130281 SPiRE rT
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: February 23, 2018
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable chronic central pain conditions including headaches. This study aims to 1) assess the effect of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS with function magnetic resonance imaging (fMRI).

Description:

This study will only be conducted at the Veterans Affair hospital in San Diego.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Male or female age between 18 to 50

• History of MTBI based on the clinical diagnostic criteria

• History of headache more than 3 months

• No prior experience of TMS treatment

• Pre-treatment headache intensity M-VAS 30(0-100 scale) and average daily headache NPS 3(0-10 scale)

• At least one headache exacerbation per day

• A normal brain MRI in the past 3 months

Exclusion Criteria:

• Pregnancy

• History of pacemaker implant

• Any ferromagnetic(e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI

• History of dementia, major psychiatric diseases, or life threatening diseases

• Presence of any other chronic neuropathic pain states

• History of seizure

• Pending litigation

• Lack of ability to understand the experimental protocol and to adequately communicate in English

• History of chronic headache prior to the incidence of MTBI

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Headache
• TBI (Traumatic Brain Injury)

Intervention

Device:
• Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
• Sham Transcranial Magnetic Stimulation
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)	The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.	Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
Primary	Percent Change in Persistent Headache Intensity	The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results. The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.	Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
Primary	Percent Change in Persistent Headache Prevalence	The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month. The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no. The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points. A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.	Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.
Secondary	Percent Change in Depression Score From Baseline to 1-Week Post-treatment	Subjects assessed how their headaches interfered with their mood through the Hamilton Rating Scale for Depression assessment at baseline, 1-week follow-up and 1-month follow-up. The outcome was measured by adding the score of each question on the assessment and then comparing the averaged scores at the different time points. The larger the depression score, the more severe the depression. A larger percent change in depression score indicates a change in the severity of the depression.	Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.