Image-guided, Robotically Delivered TMS Treatment for Combat-Related PTSD
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/21/2019 |
| Start Date: | July 5, 2017 |
| End Date: | August 2019 |
Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related PTSD: a Double-Blind, Randomized Comparison to Sham TMS
Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral
prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a
safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the
large variability in the magnitude of clinical outcomes reported is likely related to the
current lack of knowledge of ideal side of stimulation (left vs right) and the limited
precision in the targeting of brain circuits needed to obtain an optimal treatment response.
In this protocol the investigators will: 1) generate individualized treatment plans based on
an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based
connectivity analysis to guide the delivery of adjunct, imaging-based & robotically delivered
rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program
providing integrated evidence-based psychotherapy and pharmacological management (Treatment
as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as
other indicators of clinical change, to determine whether compared with TAU, addition of
adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed
to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the
potential correlation of connectivity changes with clinical outcomes.
prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a
safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the
large variability in the magnitude of clinical outcomes reported is likely related to the
current lack of knowledge of ideal side of stimulation (left vs right) and the limited
precision in the targeting of brain circuits needed to obtain an optimal treatment response.
In this protocol the investigators will: 1) generate individualized treatment plans based on
an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based
connectivity analysis to guide the delivery of adjunct, imaging-based & robotically delivered
rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program
providing integrated evidence-based psychotherapy and pharmacological management (Treatment
as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as
other indicators of clinical change, to determine whether compared with TAU, addition of
adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed
to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the
potential correlation of connectivity changes with clinical outcomes.
The investigators propose a randomized, double-blind, sham-controlled, 20 consecutive day
trial of adjunct rTMS to the right DLPFC for ADM with PTSD receiving TAU at Laurel Ridge
Treatment Center (LRTC; San Antonio, TX). Methods: Consenting ADM receiving TAU for PTSD at
LRTC will be randomized to receive 20 consecutive days of adjunct rTMS according to one of
these two treatment arms: Arm 1 TAU plus rTMS to the right DLPFC and Arm 2 TAU plus sham
rTMS. At UTHSCSA's Research Imaging Institute (RII), where all brain imaging will be
conducted, rTMS treatment plans will be generated based on (pre-treatment) anatomical and
functional magnetic resonance imaging (fMRI) to guide the optimal robotic positioning of the
TMS coil to accurately target each subject's DLPFC. Initial diagnostic interview and weekly
clinical follows ups will be conducted at the LRTC by research clinicians blinded to
subjects' research group. A comparison of baseline brain connectivity measurements with
subjects' neuroimaging follow ups conducted at treatment Week 3 will be conducted to identify
network connectivity changes potentially associated to treatment response.
trial of adjunct rTMS to the right DLPFC for ADM with PTSD receiving TAU at Laurel Ridge
Treatment Center (LRTC; San Antonio, TX). Methods: Consenting ADM receiving TAU for PTSD at
LRTC will be randomized to receive 20 consecutive days of adjunct rTMS according to one of
these two treatment arms: Arm 1 TAU plus rTMS to the right DLPFC and Arm 2 TAU plus sham
rTMS. At UTHSCSA's Research Imaging Institute (RII), where all brain imaging will be
conducted, rTMS treatment plans will be generated based on (pre-treatment) anatomical and
functional magnetic resonance imaging (fMRI) to guide the optimal robotic positioning of the
TMS coil to accurately target each subject's DLPFC. Initial diagnostic interview and weekly
clinical follows ups will be conducted at the LRTC by research clinicians blinded to
subjects' research group. A comparison of baseline brain connectivity measurements with
subjects' neuroimaging follow ups conducted at treatment Week 3 will be conducted to identify
network connectivity changes potentially associated to treatment response.
Inclusion Criteria:
1. Male or female English-speaking active duty or recently retired veteran patients who
have deployed post 9/11 receiving treatment at LRTC between the ages of 18-65 years;
2. Patients must have a diagnosis of PTSD confirmed by the Clinician-Administered PTSD
Scale (CAPS-5) at screening,
3. Subjects must have a minimum PTSD Symptom Checklist for DSM-V (PCL-5) symptom severity
rating of 25.
Exclusion Criteria:
1. Subjects with a diagnostic history of bipolar disorder, schizophrenia or
schizoaffective disorder as documented in the medical record.
2. Substance use disorder during the 12 months prior to screening; except that Mild -
Moderate, but not Severe, Alcohol Use Disorder (using DSM-5 criteria) will be allowed
as determined by LRTC medical provider review.
3. Any history or signs of serious medical or neurological illness including seizure
disorders. Except for seizures, a subject with a clinical abnormality may be included
only if the study clinician considers the illness will not introduce additional risk
and will not interfere with the study procedures. This will be determined during the
screening phase via self-report and/or medical history review.
4. History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or
more as determined by the History of Head Injuries questionnaire.
5. Females will be excluded if they are pregnant (i.e. positive pregnancy test identified
after their LRTC intake).
6. Any history or signs of metal objects deemed unsafe for MRI or that may adversely
affect image quality of the brain region (e.g. surgical clips, cardiac pacemakers,
metal implants, etc.) in the body at the time of screening as indicated by
self-report. MRI can have risks for persons with foreign bodies implanted in their
body.
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