Influence of Temporo-occipital Transcranial Magnetic Brain Stimulation on Aversive Episodic Memory Performance (SAME)

July 28, 2025 updated by: Prof. Dominique de Quervain, MD

A Pilot Study on the Influence of Temporo-occipital Transcranial Magnetic Brain Stimulation on Aversive Episodic Memory Performance

A pilot study, examining the effect of repeated transcranial magnetic brain stimulation (rTMS) on the formation of memories with negative valence. The investigators hypothesize that an effective rTMS protocol to reduce memory performance for adverse events can be found.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4055
        • University of Basel, Division of Cognitive Neuroscience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female
  • Generally healthy
  • Normotensive (BP 90/60mmHg - 140/90mmHg)
  • BMI: 19 - 30 kg/m2
  • Age: 18 - 30 years
  • Fluent German-speaking

Exclusion Criteria:

  • Metal in the brain, skull or elsewhere in the body (e.g., splinters, fragments, clips, etc.)
  • Implanted neurostimulator (e.g., DBS, epidural/subdural, VNS)
  • Cardiac pacemaker or intracardiac lines
  • Medication infusion device
  • Nonremovable Piercings in the head area, pivot teeth (retainers are no exclusion criterion)
  • Tattoos (head area) less than 3 months old or older than 20 years
  • Condition after neurosurgery
  • Hearing problems or tinnitus
  • Not able to sit still due to tremor, tics, itching
  • History of repeated syncope
  • Head trauma diagnosed as concussion or associated with loss of consciousness
  • diagnosis of epilepsy, or a convulsion or a seizure in the past of the participant or his/her close family
  • TMS in the past showing problems
  • Surgical procedures to spinal cord
  • Spinal or ventricular derivations
  • Alcohol or drug intake 48 hours before start of visits
  • Regular intake of any medication or CNS-active medication 48h before visit
  • rMT above the limits of rTMS device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cTBS 50 Hz experiment
Active brain stimulation on the temporo-occipital cortex using the cTBS 50 Hz protocol.
Device: rTMS (cTBS 50Hz experiment)

rTMS using cTBS protocol with the following characteristics:

  • Frequency: trains of 50 Hz (3 pulses) every 200ms (frequency of 5 Hz, in the range of theta band)
  • Intensity: 80% of resting motor threshold (rMT)
  • Location: consecutively on the left and right temporo-occipital cortex (MNI coordinates: left hemisphere: -50, -72, 4; right hemisphere:50, -66, 0)
  • Duration: 40 seconds for each hemisphere, 80 seconds in total.
  • Timing: Immediately before viewing pictures in pictorial memory task (off-line)
Sham Comparator: cTBS sham
Sham brain stimulation on the temporo-occipital cortex using the cTBS 50Hz protocol pattern
Device: rTMS (cTBS sham)

rTMS using cTBS protocol with the following characteristics:

  • Frequency: trains of 50 Hz (3 pulses) every 200ms (frequency of 5 Hz, in the range of theta band)
  • Intensity: 0%
  • Location: consecutively on the left and right temporo-occipital cortex (MNI coordinates: left hemisphere: -50, -72, 4; right hemisphere:50, -66, 0)
  • Duration: 40 seconds for each hemisphere, 80 seconds in total.
  • Timing: Immediately before viewing pictures in pictorial memory task (off-line)
Active Comparator: cTBS 50Hz active control
Active brain stimulation on the right superior frontal cortex using the cTBS 50 Hz protocol
Device: rTMS (cTBS 50 Hz active control)

rTMS using cTBS protocol with the following characteristics:

  • Frequency: trains of 50 Hz (3 pulses) every 200ms (frequency of 5 Hz, in the range of theta band)
  • Intensity: 80% of resting motor threshold (rMT)
  • Location: Right superior frontal cortex
  • Duration: 40 seconds for each hemisphere, 80 seconds in total.
  • Timing: Immediately before viewing pictures in pictorial memory task (off-line)
Experimental: High frequency
Active brain stimulation on the temporo-occipital cortex using the 20Hz protocol
Device: rTMS (high frequency)

rTMS using high frequency protocol with the following characteristics:

  • Frequency: 20 Hz
  • Intensity: 120% of rMT for rMT < 54% & 65% of MSO for rMT ≥ 54%
  • Location: temporo-occipital cortex of the dominant brain hemisphere
  • Duration: 20 minutes, continuously
  • Timing: During the pictorial memory task (on-line) 1 second stimulation and 14 seconds inter-train interval for 76 trains resulting in a total of 1520 pulses.
Experimental: Low frequency
Active brain stimulation on the temporo-occipital cortex using the 1Hz protocol
Device: rTMS (low frequency)

rTMS using Low frequency protocol with the following characteristics:

  • Frequency: 1 Hz
  • Intensity: 110% of rMT
  • Location: temporo-occipital cortex of dominant brain hemisphere (MNI left hemisphere: -50, -72, 4; right hemisphere:50, -66, 0)
  • Duration: 30 minutes, continuously
  • Timing: Starting 10 minutes before and continuing during the picture viewing and valence rating of the pictures of the memory task (on-line).
Experimental: cTBS 30Hz
Active brain stimulation on the temporo-occipital cortex using the cTBS 30 Hz protocol.
Device: rTMS (cTBS 30 Hz)
  • Bilateral continuous theta burst stimulation (cTBS) 30 Hz:
  • Frequency: trains of 30 Hz (3 pulses) every 167 ms (frequency of 6 Hz, in the range of theta band)
  • Intensity: 100% of resting motor threshold (rMT)
  • Location: consecutively on left and right temporo-occipital cortex
  • Duration: 33.3 seconds for each side
  • Timing: Immediately before pictorial memory task (off-line)
Active Comparator: cTBS 30 Hz Active control
Active brain stimulation on the right superior frontal cortex using the cTBS 30 Hz protocol
Device: rTMS ( cTBS 30 Hz active control)
  • Bilateral continuous theta burst stimulation (cTBS) 30 Hz:
  • Frequency: trains of 30 Hz (3 pulses) every 167 ms (frequency of 6 Hz, in the range of theta band)
  • Intensity: 100% of resting motor threshold (rMT)
  • Location: consecutively on right superior frontal cortex
  • Duration: 33.3 seconds for each side
  • Timing: Immediately before pictorial memory task (off-line)
Active Comparator: High frequency Active control
Active brain stimulation on the right superior frontal cortex using the 20 Hz online protocol
Device: rTMS (high frequency active control)
  • Frequency: 20 Hz
  • Intensity: 120% of rMT for rMT < 54% & 65% of MSO for rMT ≥ 54%
  • Location: right superior frontal cortex of the dominant brain hemisphere
  • Duration: 20 minutes, continuously
  • Timing: During the pictorial memory task (on-line) 1 second stimulation and 14 seconds inter-train interval for 76 trains resulting in a total of 1520 pulses.
Active Comparator: Low frequency Active control
Active brain stimulation on the right superior frontal cortex using the 1 Hz offline protocol
Device: rTMS (low frequency active control )
  • Frequency: 1 Hz
  • Intensity: 110% of rMT
  • Location: Right superior frontal cortex of the dominant brain hemisphere
  • Duration: 6 minutes
  • Timing: Starting 1 minutes before and continuing during the memory task (Online)
Sham Comparator: High frequency sham
Brain stimulation on the dominant temporo-occipital cortex using 10% maximum system output (MSO) and 20 Hz online protocol.
Device: rTMS (high frequency sham)
  • Frequency: 20 Hz
  • Intensity: 10% of MSO
  • Location: temporo-occipital cortex of the dominant brain hemisphere
  • Duration: 20 minutes, continuously
  • Timing: During the pictorial memory task (on-line) 1 second stimulation and 14 seconds inter-train interval for 76 trains resulting in a total of 1520 pulses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
memory recall performance
Time Frame: On average 1 hour after intervention
The difference between valence specific (negative, positive, and neutral) memory performance as assessed by a standard picture recall episodic memory task.
On average 1 hour after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Working memory performance
Time Frame: On average 1 hour after intervention
Working memory performance measured by n-back task
On average 1 hour after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dominique de Quervain, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dominique de Quervain, Prof. MD, University of Basel, Research Platform Molecular and Cognitive Neuroscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-00392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request

IPD Sharing Access Criteria

All IPD (de-identified) that underlie results in a publication will be shared upon reasonable request for scientific purposes. A reasonable request consists of a short description of the scientific purpose. Requests will be reviewed by the team of the principle investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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