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Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

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ClinicalTrials.gov Identifier: NCT03819608
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Theresa Pape, Edward Hines Jr. VA Hospital

Brief Summary:
This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI and PTSD.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Post Traumatic Stress Disorder Device: real iTBS Behavioral: real APT Behavioral: placebo APT Device: placebo iTBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2024

Arm Intervention/treatment
Experimental: real APT+ real iTBS
real APT+ real iTBS included 30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. iTMS will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right dorsolateral prefrontal cortex at 80% active motor threshold .
Device: real iTBS
Intermittent Theta Burst Stimulation (iTBS) is a form of repetitive transcranial magnetic stimulation (rTMS), which uses short magnetic field pulses applied to the scalp to induce currents in the underlying brain. iTBS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).
Other Name: intermittent Theta Burst Stimulation

Behavioral: real APT
APT-III is an attention processing training program
Other Name: Attention Processing Training-III

Active Comparator: real APT + placebo iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
Behavioral: real APT
APT-III is an attention processing training program
Other Name: Attention Processing Training-III

Device: placebo iTBS
delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).
Other Name: sham intermittent Theta Burst Stimulation

Active Comparator: placebo APT+ real iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Bursts of TMS pulses will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right DLPFC at 80% active motor threshold .
Device: real iTBS
Intermittent Theta Burst Stimulation (iTBS) is a form of repetitive transcranial magnetic stimulation (rTMS), which uses short magnetic field pulses applied to the scalp to induce currents in the underlying brain. iTBS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).
Other Name: intermittent Theta Burst Stimulation

Behavioral: placebo APT
computerized cognitive training
Other Name: Active Control APT

Active Comparator: placebo APT+ placebo iTBS
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
Behavioral: placebo APT
computerized cognitive training
Other Name: Active Control APT

Device: placebo iTBS
delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).
Other Name: sham intermittent Theta Burst Stimulation




Primary Outcome Measures :
  1. Change in the Mayo Portland Adaptability Inventory (MPAI) [ Time Frame: baseline, 5 weeks, 10 weeks, 20 weeks ]
    Self-reported ability, adjustment and community participation. It is comprised of 30 items and three subscales: Ability Index, Adjustment Index and Participation Index. Items are scored on a 5-point Likert scale, with lower scores indicating higher levels of functioning.


Secondary Outcome Measures :
  1. change in the PTSD Checklist (PCL) [ Time Frame: baseline, 5 weeks, 10 weeks, 20 weeks ]
    20-item self-report measure assessing the distress associated with PTSD symptoms. The higher the score, the worse the symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age and no older than 60 years of age
  • 3 months to 10 years post exposure to mTBI event
  • Have co-occurring mTBI and PTSD as defined by the Symptom Attribution and Classification Algorithm (SACA) and the Clinically Administered PTSD Scale for DSM-V (CAPS-5)

Exclusion Criteria:

  • Participating in another research study
  • Non-fluent in English (speaking and reading)
  • History of epilepsy pre-injury
  • Receiving antiepileptic treatment for documented active seizures in the past 6 months
  • Taking medications that lower seizure threshold including antipsychotics, buproprion, trazodone and tramadol
  • History of surgery on blood vessels in brain and/or valves of the heart
  • History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders
  • History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)
  • Significant heart disease as determined by physician review of medical chart
  • Pregnant at time of enrollment or any time during study participation
  • MRI or TMS/iTBS contraindications such as claustrophobia, metal in eyes/face or brain
  • Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips
  • Diagnosis of moderate or severe TBI (loss of consciousness > 30 minutes, alteration of consciousness > 24 hours, post traumatic amnesia or neuropsychological testing results
  • Mental health medications have been altered within the month preceding study screening
  • Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
  • Testing positive for opiates and do not have a prescription for opiates. If on prescription opiates and taking more than the equivalent of 200 mg of morphine per day.
  • Taking tricyclic antidepressants
  • Questionably valid test performance as indicated by a score of ≤ 85% on the Immediate Recognition, Delayed Recognition or Consistency Scales of the Medical Symptom Validity Test (MSVT) and clinical determination of questionable performance validity by a neuropsychologist on the research team
  • Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).
  • Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.
  • Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5
  • Severe alcohol use disorder defined by ≥ 4 symptoms on the SCID-5

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): NCT03819608


Contacts
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Contact: Catherine M Kestner 708-878-0578 Catherine.Kestner@va.gov
Contact: Ann Guernon, MS 708-202-8387 ext 114 ann.guernon@va.gov

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60141
Contact: Ann Guernon, MS, CCC-SLP, CCRC    708-2028387 ext 23114    ComaResearch@va.gov   
Edward Hines, Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141
Contact: Theresa Pape, DrPH    708-202-4953    ComaResearch@va.gov   
Sponsors and Collaborators
Theresa Pape
Investigators
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Principal Investigator: Theresa LB Pape, Dr.PH Edward Hines Jr. VA Hospital

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Responsible Party: Theresa Pape, Research Health Scientist, Edward Hines Jr. VA Hospital
ClinicalTrials.gov Identifier: NCT03819608     History of Changes
Other Study ID Numbers: 1034818
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: FITBIR

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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

Keywords provided by Theresa Pape, Edward Hines Jr. VA Hospital:
mTBI
PTSD
intermittent theta burst stimulation
cognitive training
neuroimaging

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders
Head Injuries, Closed
Wounds, Nonpenetrating