Neuromodulation and Neurorehabilitation for mTBI Plus PTSD

Post Traumatic Stress Disorder Clinical Trial

Official title:

Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03819608
• Other study ID #: 1034818
• Status: Recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: March 2024

Study information

• Verified date: August 2020
• Source: Edward Hines Jr. VA Hospital
• Contact: Catherine M Kestner
• Phone: 708-878-0578
• Email: Catherine.Kestner[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI and PTSD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2024
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

• 3 months to 10 years post exposure to mTBI event

• Have co-occurring mTBI and PTSD as defined by the Symptom Attribution and Classification Algorithm (SACA) and the Clinically Administered PTSD Scale for DSM-V (CAPS-5)

Exclusion Criteria:

• 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, buproprion, 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

• Mental health medications have been altered within the month preceding study screening

• 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.

• Taking tricyclic antidepressants

• 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 = 4 symptoms on the SCID-5

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• 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).

Behavioral:
• real APT
APT-III is an attention processing training program
• placebo APT
computerized cognitive training

Device:
• 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).

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Theresa Pape

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline, 5 weeks, 10 weeks, 20 weeks