NCT03756584

Brief Summary

Recent animal research indicates that excitatory brain stimulation opens a time window of increased neural plasticity that permits remodeling of neural representations. Repetitive transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by reducing proactive interference but human research is missing. Therefore, it is the aim of this study to investigate the effects of intermittent theta-burst stimulation (iTBS), a potent form of excitatory brain stimulation, on associative memory. Twenty right handed healthy participants will receive 3 minutes of iTBS or sham stimulation of the left lateral parietal cortex after memorizing a set of 20 face-word associations. Recall capacity will be tested directly before and after stimulation. Participants will then learn a new combination of associations using the same set of stimuli, followed by an evaluation of their recall capacity. It is hypothesized that iTBS compared to sham stimulation will reduce recall capacity directly after the stimulation but increase recall capacity of the newly learned associations due to reduced proactive interference. This study may not only pave the way towards a new understanding of the mechanism of action of brain stimulation, but can also help in developing new treatment strategies for neuropsychiatric disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable healthy

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 3, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1.8 years

First QC Date

November 22, 2018

Last Update Submit

August 16, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in recall capacity

    Change in the number of correct associations of a face-word association memory test

    Change from baseline to directly after stimulation (~6 min after baseline)

Study Arms (2)

Intermittent theta-burst stimulation

EXPERIMENTAL

iTBS will be performed on the left lateral parietal cortex

Device: Theta-burst stimulation

Control stimulation

ACTIVE COMPARATOR

iTBS will be performed on the vertex

Device: Theta-burst stimulation

Interventions

Theta-burst stimulationDEVICE

iTBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005) and consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses per session (3x10x20)

Also known as: Transcranial Magnetic Stimulation
Control stimulationIntermittent theta-burst stimulation

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • education level of primary six or above
  • right-handedness
  • normal or corrected-to-normal vision

You may not qualify if:

  • seizures in medical history
  • current or past psychiatric disorders or severe internal or neurological illness
  • substance abuse or dependence
  • intake of medication that is known to affect the excitation threshold

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Georg S Kranz, PhD

    Department of Rehabilitation Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: single-blind parallel-group crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 28, 2018

Study Start

March 3, 2019

Primary Completion

December 3, 2020

Study Completion

December 3, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Behavioral data may be shared with other researchers

Locations

HK(1)