Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder

NCT02853032 | Completed Results DMC FDA Device

• 1 other identifier: HSC20160191H
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Severity as Measured by the PTSD Checklist (PCL-5)

  The PCL-5 is a 20-item measure that assesses the presence and severity of PTSD symptoms. Responders are asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score. Severity can be determined adding scores of each item together to determine a total score. The range is 0-80, with a lower score suggesting a lower incidence of PTSD. A total score of 33 or higher suggests the patient needs further assessment to confirm a diagnosis of PTSD.

  Baseline to three weeks (the conclusion of rTMS treatment)

Secondary Outcomes (34)

• Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)

  Baseline to three weeks (the conclusion of rTMS treatment)

• Change in Depression Severity as Measured by the Montgomery-Ashberg Depression Rating Scale (MADRS)

  Baseline to three weeks (the conclusion of rTMS treatment)

• Change in PTSD Severity as Measured by the PTSD Checklist for DSM-5 (PCL-5)

  Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)

• Change in PTSD Severity as Measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)

• Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)

  Baseline to seven weeks (four weeks after the conclusion of rTMS treatment)

Study Arms (2)

Active rTMS to the right DLPFC

ACTIVE COMPARATOR

Active repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, active rTMS will be delivered at 20 Hertz (Hz) in 2 sec trains with 14 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week for 20 consecutive days.

Device: Active repetitive transcranial magnetic stimulation; Device: robotic arm

Sham rTMS to the right DLPFC

PLACEBO COMPARATOR

Sham repetitive transcranial magnetic stimulation will be delivered to the right DLPFC using connectivity-based, image-guided aiming with the rTMS coil positioned using a robotic arm. In this arm, sham rTMS will be delivered at 20 Hz in 2 sec trains with 14 sec inter-train intervals, 20 minutes/session (i.e. 1,600 pulses/session), 7 days/week for 20 consecutive days.

Device: robotic arm; Device: Sham repetitive transcranial magnetic stimulation

Interventions

Active repetitive transcranial magnetic stimulation DEVICE

The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.

Also known as: rTMS

Active rTMS to the right DLPFC

robotic arm DEVICE

This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.

Active rTMS to the right DLPFC; Sham rTMS to the right DLPFC

Sham repetitive transcranial magnetic stimulation DEVICE

The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver placebo repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.

Also known as: sham rTMS

Sham rTMS to the right DLPFC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Patients must have a diagnosis of PTSD confirmed by the Clinician-Administered PTSD Scale (CAPS-5) at screening,
• Subjects must have a minimum PTSD Symptom Checklist (PCL-5) for DSM-V symptom severity rating of 25.

You may not qualify if:

• Subjects with a diagnostic history of bipolar disorder, schizophrenia or schizoaffective disorder as documented in the medical record.
• 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.
• 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.
• History of traumatic brain injury (TBI) with loss of consciousness for 20 minutes or more as determined by the History of Head Injuries questionnaire.
• Females will be excluded if they are pregnant (i.e. positive pregnancy test identified after their LRTC intake).
• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Laurel Ridge Treatment Center: collaborator
• Consortium to Alleviate PTSD: collaborator

Study Sites (1)

Laurel Ridge Treatment Center

San Antonio, Texas, 78259, United States

Location

Related Publications (1)

• Boggio PS, Rocha M, Oliveira MO, Fecteau S, Cohen RB, Campanha C, Ferreira-Santos E, Meleiro A, Corchs F, Zaghi S, Pascual-Leone A, Fregni F. Noninvasive brain stimulation with high-frequency and low-intensity repetitive transcranial magnetic stimulation treatment for posttraumatic stress disorder. J Clin Psychiatry. 2010 Aug;71(8):992-9. doi: 10.4088/JCP.08m04638blu. Epub 2009 Dec 29.

  PMID: 20051219 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Felipe S. Salinas, Ph.D.
• Organization: University of Texas Health -- San Antonio

salinasf@uthscsa.edu

210-567-8214

Study Officials

• Felipe S Salinas, Ph.D.

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor--Research

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 2, 2016
• Study Start: July 5, 2017
• Primary Completion: March 25, 2019
• Study Completion: March 25, 2019
• Last Updated: November 3, 2020
• Results First Posted: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)