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

Conditions

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

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60141
        • Recruiting
        • Northwestern University
        • Contact:
      • Hines, Illinois, United States, 60141
        • Recruiting
        • Edward Hines, Jr. VA Hospital
        • Contact:

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 .
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 Names:
  • intermittent Theta Burst Stimulation
Behavioral: real APT
APT-III is an attention processing training program
Other Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • intermittent Theta Burst Stimulation
Behavioral: placebo APT
computerized cognitive training
Other Names:
  • 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.
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 Names:
  • sham intermittent Theta Burst Stimulation
Behavioral: placebo APT
computerized cognitive training
Other Names:
  • Active Control APT

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

Theresa Pape

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

Keywords

Additional Relevant MeSH Terms

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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