Prefrontal iTBS on Working Memory

NCT ID: NCT05774223

Last Updated: 2023-06-26

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-06-15

Brief Summary

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The investigators previous pilot study showed that the brain remained activated after 3 minutes of intermittent theta burst stimulation (iTBS). Therefore, an open question remains that how long the effects will last and when the maximum effects will be achieved. In addition, many pioneering works showed the positive effects of repetitive transcranial magnetic stimulation (rTMS) on working memory. Intermittent theta burst stimulation (iTBS) is a patterned form of rTMS, it has shown a non-inferior efficacy in depression but with a much shorter time (approximately 3 mins) than traditional rTMS (approximately 40 mins).

As discussed above, this study aims to investigate the effects of prefrontal iTBS on working memory using concurrent iTBS/fNIRS and to explore the duration of the effects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Healthy volunteers will receive iTBS two times with active or sham stimulation separated by one week to investigate the effect duration of iTBS on working memory
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Participants will not be informed of the type of stimulation

Study Groups

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Active iTBS on working memory

Participants will receive active 80% rMT iTBS over the left DLPFC in this arm. The working memory assessments will be performed pre-stimulation and at 0-, 10-, 20-, 30-, and 40-min post-stimulation. The working memory assessment is measured using a 2-minute 3-back task. The fNIRS will monitor the prefrontal hemoglobin change throughout the whole procedure.

Group Type ACTIVE_COMPARATOR

Transcranial magnetic stimulation (TMS)-active

Intervention Type DEVICE

Active intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).

Sham iTBS on working memory

Participants will receive sham 80% rMT iTBS over the left DLPFC (by putting the coil perpendicular to the left DLPFC) in this arm. The working memory assessments will be performed pre-stimulation and at 0-, 10-, 20-, 30-, and 40-min post-stimulation. The working memory assessment is measured using a 2-minute 3-back task. The fNIRS will monitor the prefrontal hemoglobin change throughout the whole procedure.

Group Type SHAM_COMPARATOR

Transcranial magnetic stimulation (TMS)-sham

Intervention Type DEVICE

Sham intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). The coil will be placed perpendicular to the left DLPFC. A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).

Interventions

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Transcranial magnetic stimulation (TMS)-active

Active intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).

Intervention Type DEVICE

Transcranial magnetic stimulation (TMS)-sham

Sham intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). The coil will be placed perpendicular to the left DLPFC. A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* right-handed participants
* normal or corrected-to-normal vision

Exclusion Criteria

* a current or past diagnosis of any neurological or psychiatric disorder
* any severe medical conditions, seizure, and pregnancy
* contraindication to TMS (e.g., with mental implants)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Georg Kranz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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HSEARS20200120005-03

Identifier Type: -

Identifier Source: org_study_id

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