Characterization and Modulation of Traumatic Memories in PTSD Patients Using Transcranial Magnetic Stimulation (TMS)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to learn if non-invasive neurostimulation of memory-related brain areas works to treat intrusive memory symptoms in adults patients with posttraumatic stress disorder (PTSD). It will also learn about the effect of this neuromodulation procedure on reorganization of memory-related brain networks. The main questions it aims to answer are: Does neuromodulation lower the number of times and the emotional severity participants intrusive memories? Does neuromodulation reduces the overall severity of PTSD? Researchers will compare neuromodulation targeting the hippocampus (a memory-related brain structure) to a control stimulation in an area not related to memory processes to see if hippocampus neuromodulation works to treat intrusive trauma memories and PTSD. Participants will: 1. Undergo magnetic resonance imaging (MRI) scans before and after neuromodulation to: a) determine a personalized neuromodulation target; and b) to measure changes in brain function from before to after treatment. 2. Receive hippocampus neuromodulation or a control neuromodulation once a week for 5 weeks. Keep a daily diary of their symptoms and the number of times they experience intrusive trauma memories.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 65
Healthy Volunteers: f
View:

• Aged of 20-65 years.

• Meet a diagnosis of PTSD according to DSM-5 as tested by a structured clinical interview (Clinician-Administered PTSD Scale for DSM-5 - CAPS-5).

• CAPS-5 total score greater or equal to 33.

• Endorsement of intrusive symptoms (flashbacks, nightmares, or intrusive memories) with a frequency of at least 3 times a week.

• Meeting the accepted criteria for inclusion in an MRI examination.

Locations
Other Locations
Israel
Tel Aviv University
RECRUITING
Tel Aviv
Contact Information
Primary
Yair Bar-Haim, PhD
yair1@tauex.tau.ac.il
972-3-6405465
Backup
Nitzan Censor, PhD
censornitzan@tauex.tau.ac.il
972-3-6406105
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2028-11
Participants
Target number of participants: 60
Treatments
Active_comparator: Trauma memory reactivation + targeted hippocampal TMS
Brain stimulation using repetitive transcranial magnetic stimulation (rTMS) will be given after a deliberate memory re-activation, using repetitive pulses at 1Hz frequency for 15 minutes, once a week over 5 weeks. The scalp stimulation area will be determined based on a resting state fMRI scan identifying a cortical area that is most strongly functionally connected to the left hippocampal target of each patient.
Sham_comparator: Trauma memory reactivation + targeted sham TMS
Brain stimulation using repetitive transcranial magnetic stimulation (rTMS) will be given after a deliberate memory re-activation, using repetitive pulses at 1Hz frequency for 15 minutes, once a week over 5 weeks. The scalp stimulation area will be determined based on a resting state fMRI scan identifying a cortical area that has near zero functional connectivity with the left hippocampal target of each patient.
Related Therapeutic Areas
Sponsors
Leads: Tel Aviv University

This content was sourced from clinicaltrials.gov