- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819608
Neuromodulation and Neurorehabilitation for mTBI Plus PTSD
August 13, 2020 updated by: Theresa Pape
Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine M Kestner
- Phone Number: 708-878-0578
- Email: Catherine.Kestner@va.gov
Study Contact Backup
- Name: Ann Guernon, MS
- Phone Number: 114 708-202-8387
- Email: ann.guernon@va.gov
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60141
- Recruiting
- Northwestern University
-
Contact:
- Ann Guernon, MS, CCC-SLP, CCRC
- Phone Number: 23114 708-2028387
- Email: ComaResearch@va.gov
-
Hines, Illinois, United States, 60141
- Recruiting
- Edward Hines, Jr. VA Hospital
-
Contact:
- Theresa Pape, DrPH
- Phone Number: 708-202-4953
- Email: ComaResearch@va.gov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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 .
|
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 Names:
APT-III is an attention processing training program
Other Names:
|
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.
|
APT-III is an attention processing training program
Other Names:
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 Names:
|
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 .
|
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 Names:
computerized cognitive training
Other Names:
|
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.
|
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 Names:
computerized cognitive training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, 5 weeks, 10 weeks, 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, 5 weeks, 10 weeks, 20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Theresa LB Pape, Dr.PH, Edward Hines Jr. VA Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
March 1, 2024
Study Registration Dates
First Submitted
January 15, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 28, 2019
Study Record Updates
Last Update Posted (Actual)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Trauma and Stressor Related Disorders
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Brain Injuries, Traumatic
- Brain Concussion
Other Study ID Numbers
- 1034818
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
FITBIR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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