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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05390593
Other study ID # CMRPG8L0871
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date July 31, 2023

Study information

Verified date April 2022
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date July 31, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: 1. The diagnosis of major depressive disorder according to DSM-5 2. Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4. 3. Before treatment, patient have to stop antidepressant for at least 1 weeks. 4. Capable and willing to provide informed consent. Exclusion Criteria: 1. Have a concomitant major, unstable medical or neurologic illness : - Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder. - Severe brian disease: Brain tumor, encephalitis, brian injury. 2. Intracranial implant and other ferromagnetic materials close to the head. 3. History of Seizures. 4. Cardiac pacemaker. 5. Pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
iTBS-1800
Participants in the 1800-pulse intermittent TBS (iTBS-1800) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG & More stimulator.
iTBS-1200
Participants in the 1200-pulse intermittent TBS (iTBS-1200) active stimulation group will receive three-pulse 50-Hz pulses for 2 weeks at an intensity of 80% active motor threshold (MT) to Left DLPFC, twice a day. Stimulation will use a MAG & More stimulator.

Locations

Country Name City State
Taiwan ChangGungMH Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 17-item Hamilton Depression Rating Scale 17-item Hamilton Depression Rating Scale (range from 0 to 52 with higher scores indicating more depression) Baseline, Week 1, Week 2, Week 4
Primary Change in Montgomery-Asberg Depression Rating Scale Montgomery-Asberg Depression Rating Scale (range from 0 to 54 with higher scores indicating more depression) Baseline, Week 1, Week 2, Week 4
Primary Change in Beck Anxiety Inventory Beck Anxiety Inventory (range from 0 to 63 with higher scores indicating more severe anxitey) Baseline, Week 1, Week 2, Week 4
Secondary Response rate after 2-week treatment at the end of iTBS (HDRD-17 ) Improvement > 50 % of HDRD-17 Baseline, Week 1, Week 2, Week 4
Secondary Response rate after 2-week treatment at the end of iTBS (MADRS) Improvement > 50 % of MADRS Baseline, Week 1, Week 2, Week 4
Secondary Changes in Clinical Global Index Severity Clinical Global Index Baseline, Week 1, Week 2, Week 4
Secondary Changes in Heart Rate Variability (HRV) band Heart rate variability measured by Wegene 8Z11 Baseline, Week 1, Day 3, Week 2, Week 4
Secondary Changes in EEG band Changes in EEG band before and after brain stimulation. Subject EEG activity including EEG waveform, spectrum, spectrogram, and power in the slow (0.1-1 Hz), delta (1 to 4 Hz), theta (4 to 8 Hz), alpha (8 to 12 Hz), beta (12 to 25 Hz), and gamma (25 to 70 Hz) bands. Baseline, Week 1, Day 3, Week 2, Week 4
Secondary Change in BDNF Changes in BDNF values Baseline, Week 2
Secondary Change in TSH Change in TSH values Baseline, Week 2
Secondary Change in T3 Change in T3 Baseline, Week 2
Secondary Change in T4 Change in T4 Baseline, Week 2
Secondary Change in cortisol Change in cortisol Baseline, Week 2
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