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Trial record 15 of 36 for:    fmri headache

Improving Functions in MTBI Patients With Headache by rTMS

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ClinicalTrials.gov Identifier: NCT01948947
Recruitment Status : Completed
First Posted : September 24, 2013
Results First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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).

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Device: Transcranial Magnetic Stimulation Device: Sham Transcranial Magnetic Stimulation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Functions in MTBI Patients With Headache by rTMS
Study Start Date : May 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
Device: Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.

Sham Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency) [ Time Frame: 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. ]
    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.

  2. Percent Change in Persistent Headache Intensity [ Time Frame: 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. ]
    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.

  3. Percent Change in Persistent Headache Prevalence [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Percent Change in Depression Score From Baseline to 1-Week Post-treatment [ Time Frame: 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948947


Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Albert Y Leung, MD VA San Diego Healthcare System, San Diego, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01948947     History of Changes
Other Study ID Numbers: F1359-P
H130281 SPiRE rTMS MTBI HA ( Other Identifier: San Diego VA Healthcare System )
First Posted: September 24, 2013    Key Record Dates
Results First Posted: March 26, 2018
Last Update Posted: March 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Headache
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms