- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03756584
Probing TBS-induced Neural Plasticity and Associated Effects on Learning
August 16, 2021 updated by: Dr Georg Kranz
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 Overview
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- education level of primary six or above
- right-handedness
- normal or corrected-to-normal vision
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intermittent theta-burst stimulation
iTBS will be performed on the left lateral parietal cortex
|
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)
Other Names:
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Active Comparator: Control stimulation
iTBS will be performed on the vertex
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change from baseline to directly after stimulation (~6 min after baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Georg S Kranz, PhD, Department of Rehabilitation Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2019
Primary Completion (Actual)
December 3, 2020
Study Completion (Actual)
December 3, 2020
Study Registration Dates
First Submitted
November 22, 2018
First Submitted That Met QC Criteria
November 26, 2018
First Posted (Actual)
November 28, 2018
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 16, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 1-ZVN9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Behavioral data may be shared with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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