Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639061
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Neuromodulation of the Hippocampus to Reduce Intrusive Re-Experiencing in PTSD A Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterization and Modulation of Traumatic Memories in PTSD Patients Using Transcranial Magnetic Stimulation TMS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Intrusive trauma memories are a hallmark of posttraumatic stress disorder PTSD and the least treatment responsive Thus revealing neurocognitive mechanisms associated with intrusive trauma memories has been indexed a priority Prior work shows that targeting hippocampal circuitry modulates functional connectivity among distributed cortical-hippocampal network regions and alters memory performance in healthy participants In the current clinical trial we test hypotheses on the clinical effects of such stimulation in a two-arms randomized controlled trial Trauma memory reactivation targeted hippocampal transcranial magnetic stimulation TMS R-H-TMS and Trauma memory reactivation Control TMS over the SMA R-C-TMS We will test a Hippocampus seed-based connectivity patterns - revealing the impact of the targeted stimulation on extended memory brain networks and b frequency and severity of intrusive memory symptoms The R-H-TMS vs R-C-TMS contrast will speak to specificity of the noted effects to hippocampal stimulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None