Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
NCT ID: NCT06524505
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2021-11-01
2024-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression
NCT07021508
Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
NCT01566591
rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder
NCT05964777
Effect of tDCS Combined With Pharmacological Treatments for Bipolar Mania
NCT05622552
A Study of Repetitive Transcranial Magnetic Stimulation in Bipolar Patients
NCT03207048
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
dTMS group
Participants receive active stimulation with H1 coil, consisting of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s ,1980 pulses per day. The subjects were stimulated every day for 4 weeks (except weekends).
deep Transcranial Magnetic Stimulation (dTMS) -active
with the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).
sham group
The sham stimulation was performed using the same procedures, with the sham coil.
deep Transcranial Magnetic Stimulation (dTMS) -sham
The sham stimulation was performed using the same procedures, with the sham coil.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
deep Transcranial Magnetic Stimulation (dTMS) -active
with the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).
deep Transcranial Magnetic Stimulation (dTMS) -sham
The sham stimulation was performed using the same procedures, with the sham coil.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Met standardized criteria for failure to achieve remission from pharmacological treatment in the current illness episode;
* Pharmacological treatment maintained unchanged for the four weeks preceding rTMS application；
* Able to read, verbalize understanding and voluntarily sign the informed consent form prior to performance of any study-specific procedures or assessments
Exclusion Criteria
* Ferromagnetic material close to the head;
* Cardiac pacemaker and/or implanted electronic device;
* The presence of neurological disorders (uncontrolled epilepsy, previous significant head injuries, brain surgery);
* Pregnancy or lactation;
* Significant medical and/or psychiatric comorbidities;
* Substance abuse in the last three months (not including caffeine or nicotine);
* Acute psychosis;
* Acute suicidality;
* Patient refuses to sign consent for participation in the study
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Anding Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tianjin Anding Hospital
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
dTMS-TJAH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.