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Behavioral Intervention

Neuromodulation + Neurorehabilitation for Concussion + PTSD

N/A

Waitlist Available

Led By Theresa LB Pape, Dr.PH

Research Sponsored by Theresa Pape

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age and no older than 60 years of age

3 months to 10 years post exposure to mTBI event

Must not have

Receiving antiepileptic treatment for documented active seizures in the past 6 months

Taking tricyclic antidepressants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 5 weeks, 10 weeks, 20 weeks

Summary

This trial will study the effects of a common computer attention processing training combined with transcranial magnetic stimulation on the attention systems of people with brain injuries and PTSD.

Who is the study for?

This trial is for adults aged 18-60 who have experienced a mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) between 3 months to 10 years ago. Candidates must be fluent in English, not involved in other studies, without epilepsy or severe heart conditions, not pregnant, and free from certain metal implants that affect MRI or TMS procedures.

What is being tested?

The study tests the combined effect of attention processing training (APT) with intermittent theta burst stimulation (iTBS), against placebos for each treatment. It aims to assess improvements in attention among those with mTBI plus PTSD and understand changes in their neurocognitive systems.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, lightheadedness during iTBS sessions. There's also a low risk of seizure due to magnetic stimulation but precautions are taken to minimize this.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I experienced a mild traumatic brain injury between 3 months and 10 years ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been on medication for seizures in the last 6 months.

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I am currently taking tricyclic antidepressants.

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I tested positive for opiates without a prescription, or I'm taking more than 200 mg of morphine daily with a prescription.

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I am taking prescribed stimulants for my brain and will not stop during the study.

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I am not fluent in English.

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I have had surgery on my brain's blood vessels or heart valves.

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I am taking medication that could increase my risk of seizures.

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I have had a traumatic brain injury with significant consciousness loss or memory issues.

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My mental health medications have changed in the last month.

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I have a history of brain bleeding, stroke, or conditions like Alzheimer's.

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My brain scans or eye exams show increased pressure inside my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 5 weeks, 10 weeks, 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 5 weeks, 10 weeks, 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 weeks, 10 weeks, 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the Mayo Portland Adaptability Inventory (MPAI)

Secondary study objectives

change in the PTSD Checklist (PCL)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: real APT+ real iTBSExperimental Treatment2 Interventions

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 .

Group II: placebo APT+ real iTBSActive Control2 Interventions

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 .

Group III: real APT + placebo iTBSActive Control2 Interventions

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.

Group IV: placebo APT+ placebo iTBSActive Control2 Interventions

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.

0 / 13Eligibility criteria met