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

NCT ID: NCT05847933

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Memory, Episodic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cTBS 50 Hz experiment

Active brain stimulation on the temporo-occipital cortex using the cTBS 50 Hz protocol.

Group Type EXPERIMENTAL

rTMS (cTBS 50Hz experiment)

Intervention Type DEVICE

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)

cTBS sham

Sham brain stimulation on the temporo-occipital cortex using the cTBS 50Hz protocol pattern

Group Type SHAM_COMPARATOR

rTMS (cTBS sham)

Intervention Type DEVICE

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)

cTBS 50Hz active control

Active brain stimulation on the right superior frontal cortex using the cTBS 50 Hz protocol

Group Type ACTIVE_COMPARATOR

rTMS (cTBS 50 Hz active control)

Intervention Type DEVICE

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)

High frequency

Active brain stimulation on the temporo-occipital cortex using the 20Hz protocol

Group Type EXPERIMENTAL

rTMS (high frequency)

Intervention Type DEVICE

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.

Low frequency

Active brain stimulation on the temporo-occipital cortex using the 1Hz protocol

Group Type EXPERIMENTAL

rTMS (low frequency)

Intervention Type DEVICE

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).

cTBS 30Hz

Active brain stimulation on the temporo-occipital cortex using the cTBS 30 Hz protocol.

Group Type EXPERIMENTAL

rTMS (cTBS 30 Hz)

Intervention Type DEVICE

* 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)

cTBS 30 Hz Active control

Active brain stimulation on the right superior frontal cortex using the cTBS 30 Hz protocol

Group Type ACTIVE_COMPARATOR

rTMS ( cTBS 30 Hz active control)

Intervention Type DEVICE

* 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)

High frequency Active control

Active brain stimulation on the right superior frontal cortex using the 20 Hz online protocol

Group Type ACTIVE_COMPARATOR

rTMS (high frequency active control)

Intervention Type DEVICE

* 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.

Low frequency Active control

Active brain stimulation on the right superior frontal cortex using the 1 Hz offline protocol

Group Type ACTIVE_COMPARATOR

rTMS (low frequency active control )

Intervention Type DEVICE

* 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)

High frequency sham

Brain stimulation on the dominant temporo-occipital cortex using 10% maximum system output (MSO) and 20 Hz online protocol.

Group Type SHAM_COMPARATOR

rTMS (high frequency sham)

Intervention Type DEVICE

* 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.

Interventions

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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)

Intervention Type 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)

Intervention Type 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)

Intervention Type 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.

Intervention Type 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).

Intervention Type 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.

Intervention Type 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.

Intervention Type 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)

Intervention Type 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)

Intervention Type 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)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prof. Dominique de Quervain, MD

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dominique de Quervain, MD

Director Division of Cognitive Neuroscience

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dominique de Quervain, Prof. MD

Role: STUDY_CHAIR

University of Basel, Research Platform Molecular and Cognitive Neuroscience

Locations

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University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2023-00392

Identifier Type: -

Identifier Source: org_study_id

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