NCT05774223

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2023

Shorter than P25 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

Study Start

First participant enrolled

March 1, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

March 7, 2023

Last Update Submit

June 23, 2023

Conditions

Healthy

Keywords

Theta-Burst stimulation (iTBS)Functional near-infrared spectroscopy (fNIRS)Concurrent TMS/fNIRSWorking memory

Outcome Measures

Primary Outcomes (2)

  • N-back

    The accuracy number of each n-back task

    before and post iTBS, up to 3 months

  • N-back

    The response time of each n-back task

    before and post iTBS, up to 3 months

Secondary Outcomes (1)

  • Hemoglobin change

    before and post iTBS, up to 3 months

Study Arms (2)

Active iTBS on working memory

ACTIVE COMPARATOR

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.

Device: Transcranial magnetic stimulation (TMS)-active

Sham iTBS on working memory

SHAM COMPARATOR

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.

Device: Transcranial magnetic stimulation (TMS)-sham

Interventions

Transcranial magnetic stimulation (TMS)-activeDEVICE

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).

Active iTBS on working memory
Transcranial magnetic stimulation (TMS)-shamDEVICE

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).

Sham iTBS on working memory

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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)

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be informed of the type of stimulation
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 17, 2023

Study Start

March 1, 2023

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)