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Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

Primary Purpose

Mild Traumatic Brain Injury, Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
real iTBS
real APT
placebo APT
placebo iTBS
Sponsored by
Theresa Pape
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring mTBI, PTSD, intermittent theta burst stimulation, cognitive training, neuroimaging

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting
  • Edward Hines, Jr. VA HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

real APT+ real iTBS

real APT + placebo iTBS

placebo APT+ real iTBS

placebo APT+ placebo iTBS

Arm Description

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 .

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.

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 .

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.

Outcomes

Primary Outcome Measures

Change in the Mayo Portland Adaptability Inventory (MPAI)
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

change in the PTSD Checklist (PCL)
20-item self-report measure assessing the distress associated with PTSD symptoms. The higher the score, the worse the symptoms.

Full Information

First Posted
January 15, 2019
Last Updated
August 13, 2020
Sponsor
Theresa Pape
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1. Study Identification

Unique Protocol Identification Number
NCT03819608
Brief Title
Neuromodulation and Neurorehabilitation for mTBI Plus PTSD
Official Title
Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Theresa Pape

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Post Traumatic Stress Disorder
Keywords
mTBI, PTSD, intermittent theta burst stimulation, cognitive training, neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real APT+ real iTBS
Arm Type
Experimental
Arm Description
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 .
Arm Title
real APT + placebo iTBS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo APT+ real iTBS
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
placebo APT+ placebo iTBS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
real iTBS
Other Intervention Name(s)
intermittent Theta Burst Stimulation
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
real APT
Other Intervention Name(s)
Attention Processing Training-III
Intervention Description
APT-III is an attention processing training program
Intervention Type
Behavioral
Intervention Name(s)
placebo APT
Other Intervention Name(s)
Active Control APT
Intervention Description
computerized cognitive training
Intervention Type
Device
Intervention Name(s)
placebo iTBS
Other Intervention Name(s)
sham intermittent Theta Burst Stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in the Mayo Portland Adaptability Inventory (MPAI)
Description
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.
Time Frame
baseline, 5 weeks, 10 weeks, 20 weeks
Secondary Outcome Measure Information:
Title
change in the PTSD Checklist (PCL)
Description
20-item self-report measure assessing the distress associated with PTSD symptoms. The higher the score, the worse the symptoms.
Time Frame
baseline, 5 weeks, 10 weeks, 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine M Kestner
Phone
708-878-0578
Email
Catherine.Kestner@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Guernon, MS
Phone
708-202-8387
Ext
114
Email
ann.guernon@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa LB Pape, Dr.PH
Organizational Affiliation
Edward Hines Jr. VA Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Guernon, MS, CCC-SLP, CCRC
Phone
708-2028387
Ext
23114
Email
ComaResearch@va.gov
Facility Name
Edward Hines, Jr. VA Hospital
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Pape, DrPH
Phone
708-202-4953
Email
ComaResearch@va.gov

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
FITBIR

Learn more about this trial

Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

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