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Trial record 75 of 183 for:    functional | Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Managing MTBI-related Headaches With rTMS

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ClinicalTrials.gov Identifier: NCT03314584
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Persistent headache is one of the most common debilitating symptoms in military personnel suffering from mild traumatic brain injury (MTBI). This study aims to assess the long-term effect of repetitive transcranial magnetic stimulation (rTMS) in managing MTBI related headaches for up to 2-3 months by comparing the treatment effect of active-rTMS to sham-rTMS.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This is a double-blinded study where only the statistician is aware of the randomization.
Primary Purpose: Treatment
Official Title: Long Term Efficacy of rTMS in Managing MTBI-related Headache
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2022

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 left motor cortex.
Device: Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex.

Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex.
Device: Sham Transcranial Magnetic Stimulation
Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex due to the use of a double sided Active/Sham coil used specifically for research studies.




Primary Outcome Measures :
  1. Reduce the intensity, frequency and duration of MTBI-headaches [ Time Frame: The measure will be assessed daily from baseline to the 3-month post-treatment follow up visit. ]
    The outcome measure will be quantified through the headache diary log that tracks the intensity, frequency and duration of MTBI-headaches (MTBI-HA)

  2. Change from Baseline to Post-Treatment Quality of Life scores [ Time Frame: The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. ]
    The outcome measure will be quantified through the self-assessed short form impact on quality of life (SF-36). The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100 where Lower scores = more disability and higher scores = less disability The sections include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.

  3. Change from Baseline to Post-Treatment Depression scores [ Time Frame: The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. ]
    The outcome measure will be quantified through the administered Hamilton Scale for Depression. This contains 17 items to be rated (HDRS-17), but four other questions are not added to the total score and are used to provide additional clinical information. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor.

  4. Change in attention scores from Baseline to Post-Treatment visits [ Time Frame: The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. ]
    The outcome measure will be quantified through the Connors continuous performance test for sustained and selective attention. This is administered on a laptop and is automatically scored.

  5. Change from Baseline to Post-Treatment Global Pain scores. [ Time Frame: The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. ]
    The outcome measure will be quantified through the self-assessed global pain inventory survey. Pain will be recorded at it's worst, it's best and on average over the previous 24 hours on a 0 to 10 scale. Then the pain's impact on general activity, mood, walking ability, normal work, relationships, sleep and enjoyment of life will be measured on a 0 to 10 scale and added together for an overall Global Pain score.

  6. Change from Baseline to Post-Treatment Post Traumatic Stress Disorder (PTSD) scores [ Time Frame: The measure will be assessed at the Baseline visit, 1-Month, 2-Month and 3-month post-treatment follow up visits. ]
    The outcome measure will be quantified through the administered CAPS, a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The symptoms are rated for both frequency and intensity; these two scores are summed to provide severity ratings.

  7. Change from Baseline to Post-Treatment memory scores [ Time Frame: The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. ]
    The outcome measure will be quantified through the Hopkins Verbal Learning Test (HVLT-R) for memory. When scoring the HVLT-R, the three learning trials are combined to calculate a total recall score and the delayed recall trial creates the delayed recall score.

  8. Change from Baseline to Post-Treatment Executive Functioning [ Time Frame: The measure will be assessed at the Baseline visit, 1-Week, 1-Month, 2-Month and 3-month post-treatment follow up visits. ]
    The outcome measure will be quantified through the Trail Making Test A and B and Stroop Test for executive functioning. The Trail Making Test consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. And the Stroop Test is a demonstration of interference in the reaction time of a task.


Secondary Outcome Measures :
  1. Explore the treatment effect on the pain related network of the brain [ Time Frame: Subjects will have 2 functional magnetic imaging scans, at baseline and then at the 1-week post treatment follow-up. ]
    The outcome measure will be assessed through functional magnetic imaging scans and subsequent processing.



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:

  • The following diagnostic criteria for MTBI based on the 1993 American Congress of Rehabilitation Medicine and recent recommendation from the DOD, and the current diagnostic criteria adopted by the VASDHS TBI Clinic will be used for the study. A traumatically induced physiological disruption of brain function, as manifested by at least one of the following:
  • any loss of consciousness
  • any loss of memory for events immediately before or after the accident
  • any alteration in mental state at the time of the accident, e.g.:

    • feeling dazed
    • disoriented
    • confused)
  • Focal neurologic deficit (s) that may or may not be transient but where the severity of the injury does not exceed the following:

    • loss of consciousness of approximately 30 min or less
    • after 30 min, an initial Glasgow Coma Scale score of 13-15
    • post-traumatic amnesia not greater than 24 hrs
  • In addition, the following established diagnostic criteria for " Persistent headache attributed to mild traumatic injury headache" based on the International Classification of Headache Disorder (ICHD-3) will be applied to the study subjects:

    • A. Any headache fulfilling criteria C and D
    • B. Traumatic injury to the head has occurred
    • C. Headache is reported to have developed within 7 d after one of the following:
    • 1. injury to the head
    • 2. regaining of consciousness following the injury
    • 3. discontinuation of medication(s) that impairs the ability to sense or report headache following the injury
    • D. Headache persists for >3 mo after injury to the head
    • E. Not better accounted for by another ICHD-3 diagnosis

Additional Inclusion Criteria:

  • no prior experience of TMS treatment
  • average persistent headache intensity more than 30 on the 0-100 mechanical visual analog scale(M-VAS) at the screening visit (visit 1)[64] and average persistent headache intensity score greater than 3/10 on a numerical rating scale (NRS) reported in the headache diary (between visits 1&2)
  • no history of daily persistent headache prior to the MTBI incidence

Exclusion Criteria:

  • pregnancy; To be eligible for the study and to ensure no pregnancy risk, you will need to utilize contraception or practice abstinence until your study participation is completed
  • history of pacemaker implant
  • any ferromagnetic material in the brain or body that would prohibit the patients from having a brain MRI, e.g.:

    • bullet fragment
    • shrapnel
    • device implant
  • history of dementia, major psychiatric 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 diagnoses such migraine, tension or cluster headaches prior to the incidence of MTBI.
  • history of chronic headache prior to the MTBI incidence at a frequency more than once a month lasting more than one hour.
  • evidence in the chart of recent exacerbation of depressive or anxiety symptoms, active substance dependence, suicidal intent or attempt within the previous month, and/or current psychotic symptoms

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): NCT03314584


Contacts
Contact: Valerie Metzger Smith, BS AA (858) 750-0274 valerie.metzgersmith@va.gov

Locations
United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Valerie Metzger Smith, BS AA    (858) 750-0274    valerie.metzgersmith@va.gov   
Principal Investigator: Albert Yick Leung, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Albert Yick Leung, MD VA San Diego Healthcare System, San Diego, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03314584     History of Changes
Other Study ID Numbers: B2506-I
H170053 ( Other Identifier: VA San Diego Healthcare System )
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
TBI
traumatic brain injury
transcranial magnetic stimulation
headache

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Brain Injuries
Headache
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms