Characterization and Modulation of Traumatic Memories in PTSD Patients Using Transcranial Magnetic Stimulation (TMS)
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · European Research Council (ERC)
interventional
60
1 country
1
Study Start
November 1, 2024
Actual (reported)Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2024
Actual (reported)October 15, 2024
Actual (reported)November 1, 2024
Actual (reported)October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total score
The CAPS-5 is a 30-item structured interview that can be used to make current (past month or week) diagnosis of PTSD \& make lifetime diagnosis of PTSD.
Baseline, 6 weeks, 3-months
PTSD Checklist for DSM-5 (PCL-5)
Baseline, 6 weeks, 3-months
Intrusive trauma memories diary
Through study completion, an average of 8 weeks
Patient Health Questionnaire - 9 (PHQ-9)
Baseline, 6 weeks, 3-months
credibility/expectancy questionnaire (CEQ)
Baseline
fMRI Neuroimaging
Baseline, 6 weeks
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.
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.
We will use fMRI resting state data to personalize a TMS inhibitory stimulation to a cortical location that is the most strongly connected to a deeper left hippocampal target. 5 once a week sessions of rTMS will be delivered at 1-Hz stimulation frequency for 15 minutes following trauma memory reactivation.
Tel Aviv University
Tel Aviv, Israel
Yair Bar-Haim, PhD
Tel Aviv University
First Submitted
October 9, 2024
First Posted
October 15, 2024
Study Start
November 1, 2024
Actual (reported)Primary Completion
October 2027
EstimatedONE-P TMS Military Veterans
We will use fMRI resting state data to personalize a TMS sham stimulation to a cortical location with near zero connectivity to a deeper left hippocampal target. 5 once a week sessions of rTMS will be delivered at 1-Hz stimulation frequency for 15 minutes following trauma memory reactivation.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 1, 2024
Record last verified: 2024-10
De-identified data from the study will be shared in accordance with local laws related to patient data sharing.
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Source: ClinicalTrials.gov.
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