Mild Traumatic Brain InjuryNCT03819608
Neuromodulation and Neurorehabilitation for mTBI
A study testing real iTBS and real APT in people with Mild Traumatic Brain Injury and Post Traumatic Stress Disorder, run by Northwestern University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Post Traumatic Stress Disorder
- What is being tested?
- real iTBS and real APT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2021to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age and no older than 80 years of age
- 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
Who cannot join
- 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, trazodone and tramadol
- History of surgery on blood vessels in brain and/or valves of the heart
Show all 23Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60141
Katie Kestner, PT, 708-878-0578, ckestner@sralab.org
- Active, not recruiting
Moody Neurorehabilitation Institute
Houston, Texas, 77058
About this study
Official title: 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 +/- PTSD.
- Being tested
- real iTBS, real APT, placebo APT, placebo iTBS
- Keywords
- mTBI, PTSD, intermittent theta burst stimulation, cognitive training, neuroimaging
- Medical subject headings
- Brain Concussion, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real iTBSDevice
Also called intermittent Theta Burst Stimulation
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 APTBehavioural
Also called Attention Processing Training-III
APT-III is an attention processing training program
placebo APTBehavioural
Also called Active Control APT
computerized cognitive training
placebo iTBSDevice
Also called sham intermittent Theta Burst 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).
| Study group | Role | What they receive |
|---|---|---|
| real APT+ real iTBS | Experimental | 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 . Receives: Device: real iTBS; Behavioral: real APT |
| real APT + placebo iTBS | Active comparator | 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. Receives: Behavioral: real APT; Device: placebo iTBS |
| placebo APT+ real iTBS | Active comparator | 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 . Receives: Device: real iTBS; Behavioral: placebo APT |
| placebo APT+ placebo iTBS | Active comparator | 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. Receives: Behavioral: placebo APT; Device: placebo iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 5 weeks, 10 weeks, 20 weeks
Secondary outcomes (1)
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.
Measured: baseline, 5 weeks, 10 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Apr 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Pape, Northwestern University
- Investigators
- Theresa LB Pape, Dr.PH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819608
- Sponsor's protocol ID
- 1034818
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: FITBIR
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
- ClinicalTrials.gov ID
- NCT03819608
- Acronym / sponsor ID
- 1034818
- Keywords
- mTBI, PTSD, intermittent theta burst stimulation, cognitive training, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 +/- PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| real APT+ real iTBS | Experimental | Device: real iTBS, Behavioral: real APTreal 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 APT + placebo iTBS | Active comparator | Behavioral: real APT, Device: placebo iTBS30 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. |
| placebo APT+ real iTBS | Active comparator | Device: real iTBS, Behavioral: placebo APT30 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 . |
| placebo APT+ placebo iTBS | Active comparator | Behavioral: placebo APT, Device: placebo iTBS30 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age and no older than 80 years of age
- 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
Key exclusion criteria (23 listed)
- 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, trazodone and tramadol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real iTBSAlso: intermittent Theta Burst StimulationIntermittent 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). | Device | placebo APT+ real iTBS, real APT+ real iTBS |
| real APTAlso: Attention Processing Training-IIIAPT-III is an attention processing training program | Behavioural | real APT + placebo iTBS, real APT+ real iTBS |
| placebo APTAlso: Active Control APTcomputerized cognitive training | Behavioural | placebo APT+ placebo iTBS, placebo APT+ real iTBS |
| placebo iTBSAlso: sham intermittent Theta Burst Stimulationdelivered 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). | Device | placebo APT+ placebo iTBS, real APT + placebo iTBS |
Primary outcome
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.
1 secondary outcome
change in the PTSD Checklist (PCL)
Time frame: baseline, 5 weeks, 10 weeks, 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. FITBIR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Theresa LB Pape, Dr.PH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real iTBS and real APT in people with Mild Traumatic Brain Injury and Post Traumatic Stress Disorder, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine M Kestner (708-878-0578, ckestner@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Mayo Portland Adaptability Inventory (MPAI) (time frame: baseline, 5 weeks, 10 weeks, 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.