Neuromodulation and Neurorehabilitation for mTBI

NCT03819608 | Recruiting DMC FDA Device

• 1 other identifier: 1034818
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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 +/- PTSD.

Conditions

Mild Traumatic Brain Injury; Post Traumatic Stress Disorder

Keywords

mTBI; PTSD; intermittent theta burst stimulation; cognitive training; neuroimaging

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 5 weeks, 10 weeks, 20 weeks

Secondary Outcomes (1)

• change in the PTSD Checklist (PCL)

  baseline, 5 weeks, 10 weeks, 20 weeks

Study Arms (4)

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 .

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.

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 .

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.

Behavioral: placebo APT; Device: placebo iTBS

Interventions

real iTBS DEVICE

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).

Also known as: intermittent Theta Burst Stimulation

placebo APT+ real iTBS; real APT+ real iTBS

real APT BEHAVIORAL

APT-III is an attention processing training program

Also known as: Attention Processing Training-III

real APT + placebo iTBS; real APT+ real iTBS

placebo APT BEHAVIORAL

computerized cognitive training

Also known as: Active Control APT

placebo APT+ placebo iTBS; placebo APT+ real iTBS

placebo iTBS DEVICE

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).

Also known as: sham intermittent Theta Burst Stimulation

placebo APT+ placebo iTBS; real APT + placebo iTBS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age and no older than 80 years of age
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60141, United States

RECRUITING

Moody Neurorehabilitation Institute

Houston, Texas, 77058, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Theresa LB Pape, Dr.PH

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine M Kestner

CONTACT

708-878-0578; ckestner@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 28, 2019
• Study Start: April 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)