Bipolar DisorderNCT05929183
Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
A study testing Repetitive Transcranial magnetic stimulation in people with Bipolar Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the… Read more about this study
- Who is it for?
- Ages 14 to 28 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Repetitive Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Jul 2023
- 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 14 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 14-28 years old, regardless of gender;
- Meet DSM-V diagnostic criteria for bipolar depressive episodes;
- Young Mania Rating Scale (YMRS) ≤ 6 points;
- MARDS:12-30 points.
- Han nationality, right-handed;
- More than 9 years of education.
Who cannot join
- History of severe somatic or brain organic diseases and craniocerebral trauma;
- Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
- Those who do not cooperate or cannot effectively complete the experiment;
- Drug, alcohol or other psychoactive substance abusers;
- Pregnant, lactating or planned pregnancy.
- Severe suicidal ideation and behavior
- ECT or rTMS treatment was performed within six months
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.
- Conditions
- Bipolar Disorder
- Being tested
- Repetitive Transcranial magnetic stimulation, Sham Repetitive Transcranial magnetic stimulation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial magnetic stimulationDevice
Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of depressive symptom was dorsolateral prefrontal cortex (DLPFC). In this study, we use high frequency rTMS in the occipital lobe are precisely targeted by navigation, by stimulating the primary visual cortex（V1), can affect the orbitofrontal cortex (OFC), which is functionally connected to V1, and thus affect the entire nerve ring pathway excitability, thereby rapidly, effectively and safely improving mood symptoms in the acute phase of bipolar depressive episode.
After the target was determined by fMRI navigation and positioning, the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.
Sham Repetitive Transcranial magnetic stimulationDevice
The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial magnetic stimulation | Active comparator | Not described Receives: Device: Repetitive Transcranial magnetic stimulation |
| Sham Repetitive Transcranial magnetic stimulation | Sham comparator | Not described Receives: Device: Sham Repetitive Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale（MADRS）
Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. The scale can be used to score at any time interval.
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2022
- Primary completion30 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929183
- Sponsor's protocol ID
- IIT20220081C-R1
- Status last verified
- Sep 2023
- First submitted
- 26 Jun 2023
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao X, Zhou H, Zhang X, Tang R, Gan Y, Zhuang T, Zhu Y, Qin Z, Chen Y, Fu Y, Zhang D, Xu L, Wang S, Shen Z, Hu S, Wang M. fMRI-guided V1-targeted rTMS improves depressive symptoms in adolescents and young adults with bipolar disorder: a double-blind randomized controlled trial. BMC Med. 2026 Mar 7;24(1):242. doi: 10.1186/s12916-026-04766-3.
PubMed 41792767
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
- ClinicalTrials.gov ID
- NCT05929183
- Acronym / sponsor ID
- IIT20220081C-R1
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 3 Jul 2023 (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.
The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial magnetic stimulation | Active comparator | Device: Repetitive Transcranial magnetic stimulation |
| Sham Repetitive Transcranial magnetic stimulation | Sham comparator | Device: Sham Repetitive Transcranial magnetic stimulation |
Who may qualify
- Ages
- 14 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 14-28 years old, regardless of gender;
- Meet DSM-V diagnostic criteria for bipolar depressive episodes;
- Young Mania Rating Scale (YMRS) ≤ 6 points;
- MARDS:12-30 points.
- Han nationality, right-handed;
Key exclusion criteria (7 listed)
- History of severe somatic or brain organic diseases and craniocerebral trauma;
- Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
- Those who do not cooperate or cannot effectively complete the experiment;
- Drug, alcohol or other psychoactive substance abusers;
- Pregnant, lactating or planned pregnancy.
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 |
|---|---|---|
| Repetitive Transcranial magnetic stimulationSetting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of depressive symptom was dorsolateral prefrontal cortex (DLPFC). In this study, we use high frequency rTMS in the occipital lobe are precisely targeted by navigation, by stimulating the primary visual cortex（V1), can affect the orbitofrontal cortex (OFC), which is functionally connected to V1, and thus affect the entire nerve ring pathway excitability, thereby rapidly, effectively and safely improving mood symptoms in the acute phase of bipolar depressive episode. After the target was determined by fMRI navigation and positioning, the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000. | Device | Repetitive Transcranial magnetic stimulation |
| Sham Repetitive Transcranial magnetic stimulationThe stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm. | Device | Sham Repetitive Transcranial magnetic stimulation |
Primary outcome
Montgomery-Asberg Depression Rating Scale（MADRS）
Time frame: 0-8 weeks
Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. The scale can be used to score at any time interval.
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 27 May 2026.
- Derived from this study: PubMed 41792767Zhao X, Zhou H, Zhang X, Tang R, Gan Y, Zhuang T, Zhu Y, Qin Z, Chen Y, Fu Y, Zhang D, Xu L, Wang S, Shen Z, Hu S, Wang M. fMRI-guided V1-targeted rTMS improves depressive symptoms in adolescents and young adults with bipolar disorder: a double-blind randomized controlled trial. BMC Med. 2026 Mar 7;24(1):242. doi: 10.1186/s12916-026-04766-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial magnetic stimulation in people with Bipolar Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 6 inclusion and 7 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 27 May 2026. 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 China. 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. Some participants in this study may receive a placebo. 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?
Montgomery-Asberg Depression Rating Scale（MADRS） (time frame: 0-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929183, which also lists 1 linked publication.
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 27 May 2026.