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

Prof. Dominique de Quervain, MD

Status: Completed

Conditions: Memory, Episodic

Treatments: Device: rTMS (cTBS 50Hz experiment); Device: rTMS ( cTBS 30 Hz active control); Device: rTMS (low frequency active control ); Device: rTMS (high frequency); Device: rTMS (high frequency active control); Device: rTMS (cTBS 30 Hz); Device: rTMS (cTBS 50 Hz active control); Device: rTMS (cTBS sham); Device: rTMS (high frequency sham); Device: rTMS (low frequency)

Study type: Interventional

Funder types: Other

Identifiers

NCT05847933

2023-00392

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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105 participants in 10 patient groups

cTBS 50 Hz experiment

Experimental group

Description:

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

Treatment:

Device: rTMS (cTBS 50Hz experiment)

cTBS sham

Sham Comparator group

Description:

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

Treatment:

Device: rTMS (cTBS sham)

cTBS 50Hz active control

Active Comparator group

Description:

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

Treatment:

Device: rTMS (cTBS 50 Hz active control)

High frequency

Experimental group

Description:

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

Treatment:

Device: rTMS (high frequency)

Low frequency

Experimental group

Description:

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

Treatment:

Device: rTMS (low frequency)

cTBS 30Hz

Experimental group

Description:

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

Treatment:

Device: rTMS (cTBS 30 Hz)

cTBS 30 Hz Active control

Active Comparator group

Description:

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

Treatment:

Device: rTMS ( cTBS 30 Hz active control)

High frequency Active control

Active Comparator group

Description:

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

Treatment:

Device: rTMS (high frequency active control)

Low frequency Active control

Active Comparator group

Description:

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

Treatment:

Device: rTMS (low frequency active control )

High frequency sham

Sham Comparator group

Description:

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

Treatment:

Device: rTMS (high frequency sham)