Neuromodulation and Neurorehabilitation for mTBI

ConditionsMild Traumatic Brain Injury Post Traumatic Stress Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

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).
real APT
Behavioral
APT-III is an attention processing training program
placebo APT
Behavioral
computerized cognitive training
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).

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: real APT+ real iTBSExperimental treatment 2 interventions

Group B: real APT + placebo iTBSActive comparator 2 interventions

Group C: placebo APT+ real iTBSActive comparator 2 interventions

Group D: placebo APT+ placebo iTBSActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

baseline, 5 weeks, 10 weeks, 20 weeks

Secondary outcomes

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.

Time frame

baseline, 5 weeks, 10 weeks, 20 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov

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