Depression MinorNCT04031105
Probing Homeostatic Plasticity With Priming Theta-burst Stimulation of the Dorsolateral Prefrontal Cortex
A study testing Theta-burst stimulation (TBS) in people with Depression Minor, run by Dr Georg Kranz at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression Minor
- What is being tested?
- Theta-burst stimulation (TBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 May 2021to 16 Jan 2024
- 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
- age 18-35
- education level of primary six or above
- right-handedness
- normal or corrected-to-normal vision
- being able to understand the verbal instructions
- willingness to sign the informed consent form
Who cannot join
- a history of seizures
- current or past psychiatric disorders
- current or past severe internal or neurological illness
- ferromagnetic implants <20cm from the head, cardiac pacemaker, deep brain stimulation and other common TMS exclusion criteria
- history of substance dependence or abuse within the last 3 months
- intake of any medication known to affect the excitation threshold (i.e., benzodiazepines, anticonvulsants).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
No detailed description
- Conditions
- Depression Minor
- Being tested
- Theta-burst stimulation (TBS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta-burst stimulation (TBS)Device
Also called Transcranial Magnetic Stimulation
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
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Priming sham TBS, followed by iTBS after an inter-stimulation-interval (ISI) of 0 minutes Receives: Device: Theta-burst stimulation (TBS) |
| Condition 2 | Experimental | Priming cTBS, followed by iTBS after an ISI of 0 minutes Receives: Device: Theta-burst stimulation (TBS) |
| Condition 3 | Experimental | Priming cTBS, followed by iTBS after an ISI of 10 minutes Receives: Device: Theta-burst stimulation (TBS) |
| Condition 4 | Experimental | Priming cTBS, followed by iTBS after an ISI of 20 minutes Receives: Device: Theta-burst stimulation (TBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin concentrations (Hb) during rest
Oxy- and deoxy-hemoglobin (HbO, HHb) and total Hb will be acquired using functional near-infrared spectroscopy (fNIRS)
Measured: Change from baseline Hb at 15 minutes post-stimulation
Change in hemoglobin concentrations (Hb) while participants perform an emotion stroop task and verbal fluency task
Oxy- and deoxy-hemoglobin (HbO, HHb) and total Hb will be acquired using functional near-infrared spectroscopy (fNIRS)
Measured: Change from baseline Hb at 15 minutes after stimulation
Secondary outcomes (3)
Change in reaction time during emotion stroop task
Before and after stimulation, participants will perform a emotion stroop task. Participants are asked to indicate by button press in which color (red, yellow, blue, green) the word is presented on a computer screen,("c" for red, "v" for yellow, "n" for blue, "m" for green) . The total number and the reaction time of correct response will be recorded.
Measured: Change from baseline reaction times at 15 minutes after stimulation
Change in the number of correctly responded colored words in the emotional Stroop task and correctly generated words in the verbal fluency task.
Before and after stimulation, participants will perform an emotional Stroop task as described in Outcome 3. In addition, participants will also perform a verbal fluency task, In this task, participants are required to speak out as many unique words as possible during the word generation blocks, according to a given category (for example, name animals). The category will be presented at the center of the screen. The total number of correct answers will be recorded
Measured: Change from baseline score at 15 minutes after stimulation
Change in the number of correctly recognized emotion
In addition, participants will perform an emotion-recognition accuracy task. They will be presented with 64 facial stimuli, consisting of sets of 16 sad, happy, fearful and neutral faces, in a randomized order. Faces will be presented for a maximum of 6s. Participants have to indicate the depicted emotion by button press (choice between 4 answers) within the presentation period.
Measured: Change from baseline score at 15 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start23 May 2021
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression MinorStudies 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
- Parallel groups
- Model description
- Randomized, single blind, parallel group experiment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Georg Kranz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Georg Kranz, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031105
- Sponsor's protocol ID
- PolyU 251002/19M
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing upon request
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing Homeostatic Plasticity With Priming Theta-burst Stimulation of the Dorsolateral Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT04031105
- Acronym / sponsor ID
- PolyU 251002/19M
- Conditions
- Depression Minor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Dr Georg KranzUniversity, hospital or other
- Study start
- 23 May 2021 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 24 Jul 2019 (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.
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
No detailed description
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized, single blind, parallel group experiment
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Device: Theta-burst stimulation (TBS)Priming sham TBS, followed by iTBS after an inter-stimulation-interval (ISI) of 0 minutes |
| Condition 2 | Experimental | Device: Theta-burst stimulation (TBS)Priming cTBS, followed by iTBS after an ISI of 0 minutes |
| Condition 3 | Experimental | Device: Theta-burst stimulation (TBS)Priming cTBS, followed by iTBS after an ISI of 10 minutes |
| Condition 4 | Experimental | Device: Theta-burst stimulation (TBS)Priming cTBS, followed by iTBS after an ISI of 20 minutes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age 18-35
- education level of primary six or above
- right-handedness
- normal or corrected-to-normal vision
- being able to understand the verbal instructions
Key exclusion criteria (6 listed)
- a history of seizures
- current or past psychiatric disorders
- current or past severe internal or neurological illness
- ferromagnetic implants <20cm from the head, cardiac pacemaker, deep brain stimulation and other common TMS exclusion criteria
- history of substance dependence or abuse within the last 3 months
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 |
|---|---|---|
| Theta-burst stimulation (TBS)Also: Transcranial Magnetic Stimulationintermittent (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 | Device | Condition 1, Condition 2, Condition 3, Condition 4 |
Primary outcome
Change in hemoglobin concentrations (Hb) during rest
Time frame: Change from baseline Hb at 15 minutes post-stimulation
Oxy- and deoxy-hemoglobin (HbO, HHb) and total Hb will be acquired using functional near-infrared spectroscopy (fNIRS)
Change in hemoglobin concentrations (Hb) while participants perform an emotion stroop task and verbal fluency task
Time frame: Change from baseline Hb at 15 minutes after stimulation
Oxy- and deoxy-hemoglobin (HbO, HHb) and total Hb will be acquired using functional near-infrared spectroscopy (fNIRS)
3 secondary outcomes
Change in reaction time during emotion stroop task
Time frame: Change from baseline reaction times at 15 minutes after stimulation
Change in the number of correctly responded colored words in the emotional Stroop task and correctly generated words in the verbal fluency task.
Time frame: Change from baseline score at 15 minutes after stimulation
Change in the number of correctly recognized emotion
Time frame: Change from baseline score at 15 minutes after stimulation
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 19 Sep 2024.
- Individual participant dataSharing planned: No. Sharing upon request
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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 Theta-burst stimulation (TBS) in people with Depression Minor, run by Dr Georg Kranz 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 6 inclusion and 6 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 19 Sep 2024. 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. 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?
Change in hemoglobin concentrations (Hb) during rest (time frame: Change from baseline Hb at 15 minutes post-stimulation). 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 19 Sep 2024.