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Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06372639
Enrollment
10
Registered
2024-04-18
Start date
2022-02-23
Completion date
2024-10-24
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Brief summary

Characterization and modulation of traumatic memories in PTSD patients using TMS.

Detailed description

Study goals: 1. Characterization of the cortical brain regions that are suitable for effective modulation with TMS, which has the highest connectivity to the sub-cortical regions that are in the strongest connectivity with areas that directly contribute to the formation and preservation of intrusive traumatic memories. 2. Examine the modulation of those cortical brain regions with TMS, while deliberately re-activating an intrusive traumatic memory, on the clinical symptoms of PTSD patients.

Interventions

Brain stimulation by the TMS device will be given after a deliberate memory re-activation, using repetitive pulses at 1Hz frequency for 15 minutes, the target area will be determined based on an fMRI scan in the resting state of the subject.

Sponsors

Tel Aviv University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Adults aged 20-65 of both sexes, who meet the diagnosis of PTSD according to DSM-5 as tested by a structured clinical interview (Clinician-Administered PTSD Scale - CAPS-5). The clinical interview will be performed by clinical psychologists. 2. CAPS-5 (Clinician-Administered PTSD Scale) score higher than 33. 3. Subjects who experience intrusive symptoms (flashbacks, nightmares, or intrusive memories) at least 4 times a week. 4. Only subjects with a level of Hebrew that allows a full understanding of the consent form to participate in the experiment will be included in the experiment. 5. In addition, the accepted criteria for inclusion for an MRI examination for medical purposes will be applied, according to the established procedures at the MRI Institute at the Sourasky Tel Aviv Medical Center and at the Imaging Center at Tel Aviv University.

Exclusion criteria

1. Subjects who meet the diagnosis of Complex PTSD or personality disorder. 2. Subjects who suffer or have suffered in the past from a psychotic disorder, bipolar disorder, or a developmental neuropsychological disorder (autism, mental retardation). 3. Use of psychiatric medications (except for the medications listed in section 4.a) will not be an expense criterion if the medication dosage is stable in the last three months and does not change during the study. In addition,

Design outcomes

Primary

MeasureTime frameDescription
CAPS-5 scoreBaseline, second measure after up to 12 weeks and last measure after up to 24 weeks.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.
Neurological measures of functional connectivityBaseline, after up to 12 weeksFunctional connectivity, indicating the level of synchronous activity of certain brain regions during rest (temporal correlation is usually expressed as a Pearson's r); Also to be derived from the MRI scans, and compared between the two groups over time.
Intrusive memoriesDaily for up to 12 weeksThe amount, frequency and emotional effect of intrusive traumatic memories, measured by a daily self-report of the subject.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026