NCT05847933

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

April 14, 2023

Last Update Submit

July 28, 2025

Conditions

Keywords

memoryTranscranial magnetic brain stimulationemotional valence

Outcome Measures

Primary Outcomes (1)

  • memory recall performance

    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 Outcomes (1)

  • Working memory performance

    On average 1 hour after intervention

Study Arms (10)

cTBS 50 Hz experiment

EXPERIMENTAL

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

Device: rTMS (cTBS 50Hz experiment)

cTBS sham

SHAM COMPARATOR

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

Device: rTMS (cTBS sham)

cTBS 50Hz active control

ACTIVE COMPARATOR

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

Device: rTMS (cTBS 50 Hz active control)

High frequency

EXPERIMENTAL

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

Device: rTMS (high frequency)

Low frequency

EXPERIMENTAL

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

Device: rTMS (low frequency)

cTBS 30Hz

EXPERIMENTAL

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

Device: rTMS (cTBS 30 Hz)

cTBS 30 Hz Active control

ACTIVE COMPARATOR

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

Device: rTMS ( cTBS 30 Hz active control)

High frequency Active control

ACTIVE COMPARATOR

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

Device: rTMS (high frequency active control)

Low frequency Active control

ACTIVE COMPARATOR

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

Device: rTMS (low frequency active control )

High frequency sham

SHAM COMPARATOR

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

Device: rTMS (high frequency sham)

Interventions

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 50 Hz 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: 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 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: 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)

cTBS 50Hz active control

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.

High 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).

Low frequency

* 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.

High frequency sham

* 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.

High 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)

Low frequency 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)

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 left and right temporo-occipital cortex * Duration: 33.3 seconds for each side * Timing: Immediately before pictorial memory task (off-line)

cTBS 30Hz

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel, Division of Cognitive Neuroscience

Basel, Canton of Basel-City, 4055, Switzerland

Location

MeSH Terms

Conditions

Recurrence

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Dominique de Quervain, Prof. MD

    University of Basel, Research Platform Molecular and Cognitive Neuroscience

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director Division of Cognitive Neuroscience

Study Record Dates

First Submitted

April 14, 2023

First Posted

May 8, 2023

Study Start

June 6, 2023

Primary Completion

April 1, 2025

Study Completion

May 31, 2025

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

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.

Locations