Probing Homeostatic Plasticity With Priming Theta-burst Stimulation of the Dorsolateral Prefrontal Cortex

NCT ID: NCT04031105

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-23

Study Completion Date

2024-01-16

Brief Summary

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Priming stimulation is a highly promising tool to boost the beneficial effects of therapeutic repetitive transcranial magnetic stimulation (rTMS) in psychiatry. The potentiating effects of priming stimulation, however, depend on the time interval between the priming and the test stimulation. Although it is known that too short and too long intervals have no effects, systematic studies that identify the time needed to maximize efficacy have not yet been done. Thus, there is a need for studies to investigate the effects of priming stimulation in order to fully utilize the potential benefits and advantages of this promising new rTMS protocol. This study will systematically investigate the neuromodulatory process underlying priming stimulation to enhance metaplasticity in the left dorsolateral prefrontal cortex (DLPFC) - one of the main targets for therapeutic rTMS - in individuals with subclinical depression.

The brain is a highly plastic organ and its activity can be influenced using rTMS. At the same time, the brain also has a mechanism - called homeostatic metaplasticity - which counteracts extreme plastic changes. Homeostatic metaplasticity therefore can limit the beneficial effects of brain stimulation interventions. However, priming stimulation protocols that include both a priming and a test stimulation session may utilize homeostatic metaplasticity to increase the beneficial effects of brain stimulation, although the optimal treatment parameters for priming are not known. Moreover, little is known about homeostatic metaplasticity in the DLPFC, an area that is particularly relevant for psychiatric conditions given its role in the top-down control of emotions. Here, the investigators will systematically study metaplasticity using priming theta-burst stimulation (TBS), a potent form of rTMS in the left DLPFC. Changes in blood oxygenation that signal brain activity changes will be assessed using functional near-infrared spectroscopy (fNIRS) at rest and during engagement in several cognitive tasks. The findings from this study will (1) elucidate the optimal time interval between priming and test stimulation; (2) elucidate the influence of priming TBS on emotion discrimination as well as executive function and its underlying brain activity in subclinical depression; and (3) validate homeostatic metaplasticity in the left DLPFC.

Detailed Description

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No detailed description

Conditions

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Depression Minor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, single blind, parallel group experiment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will not be told which arm they belong to

Study Groups

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Condition 1

Priming sham TBS, followed by iTBS after an inter-stimulation-interval (ISI) of 0 minutes

Group Type EXPERIMENTAL

Theta-burst stimulation (TBS)

Intervention Type DEVICE

intermittent (iTBS) and continuous (cTBS) will be applied at an intensity of 70% or 100%\* resting motor threshold (RMT) on the dorsolateral prefrontal cortex, position F3 (EEG 10-20 international system)

\*The optimal %RMT will be evaluated in a pilot study before commencement of the main study

Condition 2

Priming cTBS, followed by iTBS after an ISI of 0 minutes

Group Type EXPERIMENTAL

Theta-burst stimulation (TBS)

Intervention Type DEVICE

intermittent (iTBS) and continuous (cTBS) will be applied at an intensity of 70% or 100%\* resting motor threshold (RMT) on the dorsolateral prefrontal cortex, position F3 (EEG 10-20 international system)

\*The optimal %RMT will be evaluated in a pilot study before commencement of the main study

Condition 3

Priming cTBS, followed by iTBS after an ISI of 10 minutes

Group Type EXPERIMENTAL

Theta-burst stimulation (TBS)

Intervention Type DEVICE

intermittent (iTBS) and continuous (cTBS) will be applied at an intensity of 70% or 100%\* resting motor threshold (RMT) on the dorsolateral prefrontal cortex, position F3 (EEG 10-20 international system)

\*The optimal %RMT will be evaluated in a pilot study before commencement of the main study

Condition 4

Priming cTBS, followed by iTBS after an ISI of 20 minutes

Group Type EXPERIMENTAL

Theta-burst stimulation (TBS)

Intervention Type DEVICE

intermittent (iTBS) and continuous (cTBS) will be applied at an intensity of 70% or 100%\* resting motor threshold (RMT) on the dorsolateral prefrontal cortex, position F3 (EEG 10-20 international system)

\*The optimal %RMT will be evaluated in a pilot study before commencement of the main study

Interventions

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Theta-burst stimulation (TBS)

intermittent (iTBS) and continuous (cTBS) will be applied at an intensity of 70% or 100%\* resting motor threshold (RMT) on the dorsolateral prefrontal cortex, position F3 (EEG 10-20 international system)

\*The optimal %RMT will be evaluated in a pilot study before commencement of the main study

Intervention Type DEVICE

Other Intervention Names

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Transcranial Magnetic Stimulation

Eligibility Criteria

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Inclusion Criteria

1. age 18-35
2. education level of primary six or above
3. right-handedness
4. normal or corrected-to-normal vision
5. being able to understand the verbal instructions
6. willingness to sign the informed consent form

Exclusion Criteria

1. a history of seizures
2. current or past psychiatric disorders
3. current or past severe internal or neurological illness
5. history of substance dependence or abuse within the last 3 months
6. intake of any medication known to affect the excitation threshold (i.e., benzodiazepines, anticonvulsants).
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Georg Kranz

OTHER

Sponsor Role lead

Responsible Party

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Dr Georg Kranz

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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PolyU 251002/19M

Identifier Type: -

Identifier Source: org_study_id

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