HealthyNCT05774223
Prefrontal iTBS on Working Memory
A study testing Transcranial magnetic stimulation (TMS)-active in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial magnetic stimulation (TMS)-active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- right-handed participants
- normal or corrected-to-normal vision
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effects of Prefrontal iTBS on Working Memory in Healthy Participants: a Concurrent TMS/fNIRS Study
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.
- Conditions
- Healthy
- Being tested
- Transcranial magnetic stimulation (TMS)-active, Transcranial magnetic stimulation (TMS)-sham
- Keywords
- Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Working memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial magnetic stimulation (TMS)-sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-back
The accuracy number of each n-back task
Measured: before and post iTBS, up to 3 months
N-back
The response time of each n-back task
Measured: before and post iTBS, up to 3 months
Secondary outcomes (1)
Hemoglobin change
The hemoglobin change throughout whole procedure.
Measured: before and post iTBS, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Mar 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Georg Kranz, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774223
- Sponsor's protocol ID
- HSEARS20200120005-03
- Status last verified
- Jun 2023
- First submitted
- 7 Mar 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Prefrontal iTBS on Working Memory in Healthy Participants: a Concurrent TMS/fNIRS Study
- ClinicalTrials.gov ID
- NCT05774223
- Acronym / sponsor ID
- HSEARS20200120005-03
- Conditions
- Healthy
- Keywords
- Theta-Burst stimulation (iTBS), Functional near-infrared spectroscopy (fNIRS), Concurrent TMS/fNIRS, Working memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Active iTBS on working memory | Active comparator | Device: Transcranial magnetic stimulation (TMS)-activeParticipants 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. |
| Sham iTBS on working memory | Sham comparator | Device: Transcranial magnetic stimulation (TMS)-shamParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- right-handed participants
- normal or corrected-to-normal vision
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation (TMS)-activeActive 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). | Device | Active iTBS on working memory |
| Transcranial magnetic stimulation (TMS)-shamSham 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). | Device | Sham iTBS on working memory |
Primary outcome
N-back
Time frame: before and post iTBS, up to 3 months
The accuracy number of each n-back task
N-back
Time frame: before and post iTBS, up to 3 months
The response time of each n-back task
1 secondary outcome
Hemoglobin change
Time frame: before and post iTBS, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation (TMS)-active in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-back (time frame: before and post iTBS, up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.