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

Memory, Episodic Clinical Trial

— SAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847933
• Other study ID #: 2023-00392 BASEC_Nr
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: November 2023
• Source: University of Basel
• Contact: Ehssan Amini, MD
• Phone: +41 61 207 02 26
• Email: ehssan.amini[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Memory, Episodic

Intervention

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)
• 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)
• 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)
• 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)
• 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).

Locations

Country	Name	City	State
Switzerland	University of Basel, Division of Cognitive Neuroscience	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Working memory performance	Working memory performance measured by n-back task	On average 1 hour after intervention