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

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: Recruiting
• Conditions: Memory, Episodic
• Intervention / Treatment: Device: rTMS (cTBS experiment); Device: rTMS (cTBS sham); Device: rTMS (cTBS active control); Device: rTMS (high frequency); Device: rTMS (low frequency)

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ehssan Amini, MD; Phone Number: +41 61 207 02 26; Email: ehssan.amini@unibas.ch

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4055
      • Recruiting
      • University of Basel, Division of Cognitive Neuroscience
      • Contact: Dominique de Quervain, Prof.; Phone Number: 061 207 02 37; Email: dominique.dequervain@unibas.ch

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working memory performance	Working memory performance measured by n-back task	On average 1 hour after intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: memory; Transcranial magnetic brain stimulation; emotional valence
• Other Study ID Numbers: 2023-00392 BASEC_Nr

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