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

ConditionsPTSD - Post Traumatic Stress Disorder Intrusive Memories of Traumatic Event(s)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age20-65

SponsorTel Aviv University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Exclusion rules in TMS research (see guidelines).

Trial design

Design model

Parallel

Treatments tested in this trial

Hippocampal stimulation using repetitive transcranial magnetic stimulation (rTMS)
Device
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.
Sham stimulation using repetitive transcranial magnetic stimulation (rTMS)
Device
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Trauma memory reactivation + targeted hippocampal TMSActive comparator 1 intervention

Group B: Trauma memory reactivation + targeted sham TMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline, 6 weeks, 3-months

Secondary outcomes

PTSD Checklist for DSM-5 (PCL-5)

The PCL-5 is a 20-item self-reported measured based on the DSM-5 PTSD symptoms and assessing PTSD symptoms endorsement and severity.

Time frame

Baseline, 6 weeks, 3-months

Intrusive trauma memories diary

The amount, frequency and emotional effect of intrusive traumatic memories, measured by a daily self-report digital diary.

Time frame

Through study completion, an average of 8 weeks

Patient Health Questionnaire - 9 (PHQ-9)

Measures severity of depression symptoms as listed in the DSM-5

Time frame

Baseline, 6 weeks, 3-months

Other outcomes

credibility/expectancy questionnaire (CEQ)

Measures treatment expectancies and credibility

Time frame

Baseline

fMRI Neuroimaging

Functional connectivity, indicating the level of synchronous activity of certain brain regions during rest (temporal correlation is usually expressed as a Pearson's r). Derived from the fMRI scans, and compared between the two groups as a function of time.

Time frame

Baseline, 6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tel Aviv University

Lead sponsor

Source ClinicalTrials.gov

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