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

Sponsor

Prof. Dominique de Quervain, MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05847933

Collaborator

(none)

105

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Memory, Episodic	Device: rTMS (cTBS experiment) Device: rTMS (cTBS sham) Device: rTMS (cTBS active control) Device: rTMS (high frequency) Device: rTMS (low frequency)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cTBS experiment Active brain stimulation on the inferior occipital gyrus using the cTBS protocol.	Device: rTMS (cTBS 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 inferior occipital gyrus using the cTBS protocol	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 active control Active brain stimulation on the right superior frontal cortex using the cTBS protocol	Device: rTMS (cTBS 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 inferior occipital gyrus using the 5Hz protocol	Device: rTMS (high frequency) rTMS using high frequency protocol with the following characteristics: Frequency: 5 Hz Intensity: 100% of rMT Location: bilateral temporo-occipital cortex (MNI coordinates: left hemisphere: -50, -72, 4; right hemisphere:50, -66, 0) Duration: 2.5 seconds during the presentation of pictures (3 minutes in total) Timing: Only during the picture viewing part of memory task (On-line)
Experimental: Low frequency Active brain stimulation on the inferior occipital gyrus 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).

Outcome Measures

Primary Outcome Measures

memory recall performance [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.

Secondary Outcome Measures

Working memory performance [On average 1 hour after intervention]
Working memory performance measured by n-back task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Basel, Division of Cognitive Neuroscience	Basel	BS	Switzerland	4055

Sponsors and Collaborators

Prof. Dominique de Quervain, MD

Investigators

Study Chair: Dominique de Quervain, Prof. MD, University of Basel, Research Platform Molecular and Cognitive Neuroscience

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Dominique de Quervain, MD, Director Division of Cognitive Neuroscience, University of Basel

ClinicalTrials.gov Identifier:

NCT05847933

Other Study ID Numbers:

2023-00392 BASEC_Nr

First Posted:

May 8, 2023

Last Update Posted:

May 8, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Prof. Dominique de Quervain, MD, Director Division of Cognitive Neuroscience, University of Basel

memory

Transcranial magnetic brain stimulation

emotional valence

Study Results

No Results Posted as of May 8, 2023