Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2021-04-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
3MDR to Treat PTSD With mTBI (3MDR)
NCT03796936
Theta-Burst Neuromodulation for PTSD
NCT02769312
Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach
NCT03840369
Non Invasive Brain Stimulation for PTSD
NCT02442843
CONcussion Treatment After Combat Trauma (CONTACT)
NCT01387490
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 .
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).
real APT
APT-III is an attention processing training program
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.
real APT
APT-III is an attention processing training program
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).
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 .
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).
placebo APT
computerized cognitive training
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.
placebo APT
computerized cognitive training
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
real APT
APT-III is an attention processing training program
placebo APT
computerized cognitive training
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 3 months post exposure to mTBI event
* Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID
* Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory
Exclusion Criteria
* 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, 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
* Prescribed dosage of mental health medications have been altered within the month preceding study screening. Any participant whose mental health medication(s) has/have changed, within 30 days of study screening. The following are considered a medication change: the addition of or discontinuation of medication, a change in the dose or dosage (daily amount) of medication.
* Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
* 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.
* 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 ≥ 6 symptoms on the SCID-5
* Baseline systolic BP greater or equal to 170
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Theresa Pape
Research Health Scientist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Theresa LB Pape, Dr.PH
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwestern University
Chicago, Illinois, United States
Moody Neurorehabilitation Institute
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1034818
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.