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Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)

Florida State University logo

Florida State University

Status

Completed

Conditions

PTSD

Treatments

Procedure: Transcranial Magnetic Stimulation (TMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06016673
STUDY00003574

Details and patient eligibility

About

Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)

Full description

The purpose of the present study is to examine the effects of transcranial magnetic stimulation (TMS) on cognitive control among individuals with posttraumatic stress disorder (PTSD).

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Over 18 years of age
  • Endorse lifetime exposure to at least one Criterion A traumatic event
  • Report clinically significant posttraumatic stress disorder (PTSD) symptoms (score of ≥ 33 on the PTSD Checklist for DSM-5 [PCL-5]).

Exclusion criteria

  • Endorse medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
  • Report an unstable medical condition or any current medical condition that precludes safe participation in the trial (e.g., unstable metabolic abnormality, unstable angina, etc.)
  • Report any history or diagnosis of dementia or other cognitive disorder, which may interfere with engagement
  • Report any history or diagnosis of Severe Traumatic Brain Injury
  • Report any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness, which precludes safe participation in the trial
  • Report a primary obsessive-compulsive disorder (OCD) diagnosis
  • Report an active substance use disorder (within last 3 months) or any current substance use that precludes safe participation in the trial
  • Report suicide risk that precludes safe participation in the trial, defined as clinical impression that the participant is at significant risk for suicide (i.e., greater than moderate level of suicide risk, in accordance with the Joiner et al. (1999) suicide risk framework)
  • Report an inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
  • Report a current, planned, or suspected pregnancy

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Intermittent theta burst stimulation to right dorsolateral prefrontal cortex
Experimental group
Description:
Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)
Treatment:
Procedure: Transcranial Magnetic Stimulation (TMS)
Intermittent theta burst stimulation to vertex of the skull
Active Comparator group
Description:
Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull
Treatment:
Procedure: Transcranial Magnetic Stimulation (TMS)

Trial contacts and locations

1

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Central trial contact

Norman B Schmidt, PhD

Data sourced from clinicaltrials.gov

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