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Taking peoplePhase 2

Neuromodulation of the Hippocampus to Reduce Intrusive Re-Experiencing in PTSD: A Randomized Controlled Trial

Key facts

Who runs it
Tel Aviv University
Where
Israel1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
60 people, planned
Started
1 Nov 2024
Expected to end
Nov 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Hippocampal stimulation using repetitive transcranial magnetic stimulation (rTMS)
  • Sham stimulation using repetitive transcranial magnetic stimulation (rTMS)
Record updated
1 November 2024

Who can take part

Age
20 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Use of the following drugs: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel's dust), ketamine, gamma- hydroxybutyrate (GHB), alcohol, theophylline
  • Traumatic head injuries or head surgery
  • Meeting a diagnosis of Complex PTSD or personality disorder
  • Psychotic disorder, bipolar disorder, or a developmental neuropsychological disorder (autism, mental retardation)
  • Use of psychiatric medications (except for the medications listed in section 4.a of the study protocol if the medication dosage is stable in the last three months and does not change during the study
  • Epilepsy or use of anti-epileptic drugs
  • Exclusion rules in TMS research (see guidelines)
  • Implanted metallic body (except fillings/amalgam bites/orthodontic fixations approved for MRI), electrodes or a pacemaker
  • Migraines
  • Pregnant women
  • Hearing problems
  • Drinking alcohol 24 hours before the TMS session
  • Repeated episodes of fainting with loss of consciousness and/or an event of fainting with loss of consciousness in the past year
  • The accepted exclusion criteria for an MRI examination

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 20 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Trauma memory reactivation + targeted hippocampal TMSExisting treatment, for comparison

    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.

    Treatment: Hippocampal stimulation using repetitive transcranial magnetic stimulation (rTMS)

  • Trauma memory reactivation + targeted sham TMSSham treatment, for comparison

    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.

    Treatment: Sham stimulation using repetitive transcranial magnetic stimulation (rTMS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Characterization and Modulation of Traumatic Memories in PTSD Patients Using Transcranial Magnetic Stimulation (TMS)
Fit questions
Built from NCT06639061, who can take part
Record updated
1 November 2024