- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06104462
Exploring the Cortical Hemodynamic Variability of Prefrontal iTBS: a Concurrent TBS/fNIRS Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Georg Kranz, PhD
- Phone Number: 4838 2766
- Email: georg.kranz@polyu.edu.hk
Study Contact Backup
- Name: Weili Xia, MSc
- Phone Number: 92859726
- Email: weili-adam.xia@connect.polyu.hk
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- The Hong Kong Polytechnic University
-
Contact:
- Georg Kranz, PhD
- Phone Number: 4838 2766
- Email: georg.kranz@polyu.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthiness based on history and psychiatric assessment
- being able to hear and understand the verbal instructions
- completed at least 6 years of formal education
Exclusion Criteria:
- a current or past diagnosis of psychiatric, neurological disorders, or severe internal illness
- any conditions that will contraindicate to iTBS or fNIRS
- psychiatric disorders in their first-degree relatives
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cortical hemodynamic variability of iTBS and its courses
A group of healthy adults shall undergo repeated experimental visits with concurrent TBS/fNIRS (3≤repetition≤15). An interval of at least two days (48 hours) between the visits is required to minimize carry-over effects from the iTBS protocols. Inter- (age, gender, personality inventory, etc.) and intra-individual factors (daily mood, daily sleep quality, physical activity levels, etc.) that are potentially moderating iTBS-induced excitability changes will be explored. |
The iTBS protocol consists of 20 trains of stimulation. Each train comprises ten 3-pulse bursts, delivered at an intra-burst frequency of 50 Hz, with a 5 Hz overall frequency, followed by 8 seconds of rest. A total of 600 pulses (10*3*20) will be administered in this 3-minute iTBS protocol. Concurrent TBS/fNIRS stimulation will be applied over the left DLPFC at an intensity of 90% of the resting motor threshold (RMT), which is considered appropriate to ensure compliance and elicit robust DLPFC activation. Considering that the fNIRS optode beneath the coil increases the distance between the TMS coil and the skull by 10 mm, we will use the equation AdjMT% = MT + 2.8 * (Dsitex - Dm1). Therefore, 2.8 * 10 = 28% will be added to the normal intensity. The stimulation site over the DLPFC will be determined by the MNI coordinate (x-38, y+44, z+26) reported in previous studies.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygenated hemoglobin (HbO) change compared to baseline
Time Frame: During and post TBS-fNIRS measurement, up to 3 months
|
iTBS-induced HbO change in the DLPFC before, during and after stimulation
|
During and post TBS-fNIRS measurement, up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen saturation change compared to baseline
Time Frame: During and post TBS-fNIRS measurement, up to 3 months
|
iTBS-induced oxygen saturation change in the DLPFC before, during and after stimulation
|
During and post TBS-fNIRS measurement, up to 3 months
|
Deoxygenated hemoglobin (HbR) change compared to baseline
Time Frame: During and post TBS-fNIRS measurement, up to 3 months
|
iTBS-induced HbR change in the DLPFC before, during and after stimulation
|
During and post TBS-fNIRS measurement, up to 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Georg Kranz, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HSEARS20220812002-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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