Reduction of Trauma-induced Intrusions and Amygdala Hyperreactivity Via Non-invasive Brain Stimulation

NCT04325087 | Unknown

• 1 other identifier: COOL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study will focus on the modulation of intrusive memories via functional magnetic resonance imaging (fMRI)-guided repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex (dlPFC) directly after exposure to a traumatic video.

Conditions

Intrusive Thoughts; Post Traumatic Stress Disorder

Keywords

Amygdala; fMRI; Intrusive Thoughts; Post Traumatic Stress Disorder; TMS

Outcome Measures

Primary Outcomes (3)

• Number and quality of intrusive thoughts

  Sum and stress ratings of intrusive thoughts measured on three consecutive days after trauma exposure by an online questionnaire.

  Three days after trauma exposure

• Changes in resting state functional connectivity

  Functional connectivity data will be assessed by two 10-minutes resting state fMRI scans before and after three sessions of TMS treatment over the course of three days. The resting state fMRI analysis will focus on changes in functional connectivity between regions-of-interest (ROIs) associated with intrusive memories (prefrontal cortex, amygdala, precuneus, insula, hippocampus, cingulate cortex). Changes in functional connectivity between the first and second fMRI sessions will be computed on the first level and independent t-tests will be used to compare the verum and sham TMS groups.

  10-minutes resting state fMRI scans before and after three sessions of TMS treatment

• Changes in neural response to an emotion recognition task

  Changes between the first and second fMRI session in the blood-oxygen-level-dependent (BOLD) signal in response to happy, fearful and neutral faces as well as houses will be compared between the experimental groups. Analysis will focus on anatomically defined regions-of-interest (ROI) associated with emotion processing (i.e. amygdala, prefrontal cortex, insula, striatal areas). Changes in the neural response and functional connectivity between the first and second fMRI sessions will be computed on the first level and independent t-tests will be used to compare the verum and sham TMS groups. For analyses of fMRI data, standard procedures of the software SPM12 will be used.

  15-minutes emotional face matching fMRI task before and after three sessions of TMS treatment

Secondary Outcomes (12)

• Changes in executive functioning (One Touch Stockings of Cambridge) and attention (Rapid Visual Information Processing) during iTBS treatment

  15-minutes cognitive tasks pre/post first iTBS and pre/post last iTBS treatment

• Trauma disclosure

  Three days after trauma exposure

• Changes in electrodermal responses to the trauma video

  5 minutes before and during the trauma video

• Respiratory changes in response to the trauma video

  5 minutes before and during the trauma video

• Heart rate changes in response to the trauma video

  5 minutes before and during the trauma video

Study Arms (2)

Active iTBS

EXPERIMENTAL

Active stimulation of the dlPFC directly after trauma exposure and on the following two days

Device: iTBS

Placebo iTBS

PLACEBO COMPARATOR

Same procedure as in the active stimulation group but with a placebo stimulation imitating the sensation of a real iTBS protocol.

Device: Placebo iTBS

Interventions

iTBS DEVICE

Administration of an iTBS protocol over the dlPFC

Active iTBS

Placebo iTBS DEVICE

Administration of a placebo TMS protocol over the dlPFC

Placebo iTBS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects

You may not qualify if:

• current psychiatric illness
• current psychiatric medication or psychotherapy
• past PTSD diagnosis
• MRI contraindication (e.g. metal in body, claustrophobia)
• pregnancy

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

RECRUITING

Related Links

• Neuromodulation of Emotion (NEMO) research group

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Rene Hurlemann, MSc, MD, PhD

  University of Oldenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dirk Scheele, PhD

CONTACT

+49 (0)228 287; Dirk.Scheele@ukb.uni-bonn.de

Mitjan Morr, MSc

CONTACT

+49 (0)228 287; Mitjan.Morr@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Rene Hurlemann, M.Sc., M.D., Ph.D.

Model Details: Participants receive either three sessions of iTBS over the dorsolateral prefrontal cortex or three sessions of a placebo stimulation.

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 27, 2020
• Study Start: July 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)