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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 weeks, 10 weeks, 20 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 60 years old.
Select...
I experienced a mild traumatic brain injury between 3 months and 10 years ago.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the Mayo Portland Adaptability Inventory (MPAI)
Secondary outcome measures
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.
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Who is running the clinical trial?
Theresa PapeLead Sponsor
Theresa LB Pape, Dr.PHPrincipal InvestigatorEdward Hines Jr. VA Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You scored less than 85% on a test that checks if you are answering questions honestly, and a specialist thinks you might not be answering accurately.You have a pacemaker, defibrillator, cochlear implant, nerve stimulator, or metal clips in your head.I tested positive for opiates without a prescription, or I'm taking more than 200 mg of morphine daily with a prescription.I am taking prescribed stimulants for my brain and will not stop during the study.My mental health medications have changed in the last month.I am not fluent in English.I have been on medication for seizures in the last 6 months.You had epilepsy before the injury.I have had surgery on my brain's blood vessels or heart valves.I am taking medication that could increase my risk of seizures.I have had a traumatic brain injury with significant consciousness loss or memory issues.My doctor has diagnosed me with serious heart disease.You cannot have an MRI or TMS/iTBS if you are claustrophobic or have metal in your eyes, face, or brain.I am currently taking tricyclic antidepressants.You have a serious problem with drinking alcohol, like experiencing at least 4 symptoms identified by the SCID-5.I am between 18 and 60 years old.You have at least 4 symptoms of moderate or severe cannabis use disorder according to the SCID-5.You have recently made a plan to harm yourself or have attempted to do so.You have been diagnosed with bipolar disorder or schizophrenia.You have both a head injury and post-traumatic stress disorder, as determined by specific medical assessments.I have a history of brain bleeding, stroke, or conditions like Alzheimer's.I experienced a mild traumatic brain injury between 3 months and 10 years ago.My brain scans or eye exams show increased pressure inside my skull.
Research Study Groups:
This trial has the following groups:- Group 1: placebo APT+ real iTBS
- Group 2: real APT + placebo iTBS
- Group 3: placebo APT+ placebo iTBS
- Group 4: real APT+ real iTBS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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