HealthyNCT03756584
Probing TBS-induced Neural Plasticity and Associated Effects on Learning
A study testing Theta-burst stimulation in people with Healthy, run by Dr Georg Kranz at 1 site in Hong Kong.
Trial summary
Recent animal research indicates that excitatory brain stimulation opens a time window of increased neural plasticity that permits remodeling of neural representations. Repetitive transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by reducing proactive interference but human… 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?
- Theta-burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Mar 2019to 3 Dec 2020
- 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
- education level of primary six or above
- right-handedness
- normal or corrected-to-normal vision
Who cannot join
- seizures in medical history
- current or past psychiatric disorders or severe internal or neurological illness
- common TMS exclusion criteria
- substance abuse or dependence
- intake of medication that is known to affect the excitation threshold
Trial locations and contacts
1 site in 1 country.
About this study
Recent animal research indicates that excitatory brain stimulation opens a time window of increased neural plasticity that permits remodeling of neural representations. Repetitive transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by reducing proactive interference but human research is missing. Therefore, it is the aim of this study to investigate the effects of intermittent theta-burst stimulation (iTBS), a potent form of excitatory brain stimulation, on associative memory. Twenty right handed healthy participants will receive 3 minutes of iTBS or sham stimulation of the left lateral parietal cortex after memorizing a set of 20 face-word associations. Recall capacity will be tested directly before and after stimulation. Participants will then learn a new combination of associations using the same set of stimuli, followed by an evaluation of their recall capacity. It is hypothesized that iTBS compared to sham stimulation will reduce recall capacity directly after the stimulation but increase recall capacity of the newly learned associations due to reduced proactive interference. This study may not only pave the way towards a new understanding of the mechanism of action of brain stimulation, but can also help in developing new treatment strategies for neuropsychiatric disorders.
- Conditions
- Healthy
- Being tested
- Theta-burst stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta-burst stimulationDevice
Also called Transcranial Magnetic Stimulation
iTBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005) and consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses per session (3x10x20)
| Study group | Role | What they receive |
|---|---|---|
| Intermittent theta-burst stimulation | Experimental | iTBS will be performed on the left lateral parietal cortex Receives: Device: Theta-burst stimulation |
| Control stimulation | Active comparator | iTBS will be performed on the vertex Receives: Device: Theta-burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in recall capacity
Change in the number of correct associations of a face-word association memory test
Measured: Change from baseline to directly after stimulation (~6 min after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start3 Mar 2019
- Primary completion3 Dec 2020
- Study completion3 Dec 2020
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
- single-blind parallel-group crossover design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 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
- Investigators
- Georg S Kranz, PhD, Principal investigator, Department of Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756584
- Sponsor's protocol ID
- 1-ZVN9
- Status last verified
- Aug 2021
- First submitted
- 22 Nov 2018
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Behavioral data may be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing TBS-induced Neural Plasticity and Associated Effects on Learning
- ClinicalTrials.gov ID
- NCT03756584
- Acronym / sponsor ID
- 1-ZVN9
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dr Georg KranzUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 3 Dec 2020 (actual)
- First posted
- 28 Nov 2018 (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.
Recent animal research indicates that excitatory brain stimulation opens a time window of increased neural plasticity that permits remodeling of neural representations. Repetitive transcranial magnetic stimulation (rTMS) may thus facilitate learning of new associations by reducing proactive interference but human research is missing. Therefore, it is the aim of this study to investigate the effects of intermittent theta-burst stimulation (iTBS), a potent form of excitatory brain stimulation, on associative memory. Twenty right handed healthy participants will receive 3 minutes of iTBS or sham stimulation of the left lateral parietal cortex after memorizing a set of 20 face-word associations. Recall capacity will be tested directly before and after stimulation. Participants will then learn a new combination of associations using the same set of stimuli, followed by an evaluation of their recall capacity. It is hypothesized that iTBS compared to sham stimulation will reduce recall capacity directly after the stimulation but increase recall capacity of the newly learned associations due to reduced proactive interference. This study may not only pave the way towards a new understanding of the mechanism of action of brain stimulation, but can also help in developing new treatment strategies for neuropsychiatric disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- single-blind parallel-group crossover design
| Arm | Type | Receives |
|---|---|---|
| Intermittent theta-burst stimulation | Experimental | Device: Theta-burst stimulationiTBS will be performed on the left lateral parietal cortex |
| Control stimulation | Active comparator | Device: Theta-burst stimulationiTBS will be performed on the vertex |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- education level of primary six or above
- right-handedness
- normal or corrected-to-normal vision
Key exclusion criteria (5 listed)
- seizures in medical history
- current or past psychiatric disorders or severe internal or neurological illness
- common TMS exclusion criteria
- substance abuse or dependence
- intake of medication that is known to affect the excitation threshold
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 stimulationAlso: Transcranial Magnetic StimulationiTBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005) and consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses per session (3x10x20) | Device | Control stimulation, Intermittent theta-burst stimulation |
Primary outcome
Change in recall capacity
Time frame: Change from baseline to directly after stimulation (~6 min after baseline)
Change in the number of correct associations of a face-word association memory test
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 17 Aug 2021.
- Individual participant dataSharing planned: No. Behavioral data may be shared with other researchers
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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.
Georg S Kranz, PhD principal investigator
Department of Rehabilitation Sciences
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 in people with Healthy, 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 3 inclusion and 5 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 17 Aug 2021. 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 recall capacity (time frame: Change from baseline to directly after stimulation (~6 min after baseline)). 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 17 Aug 2021.