Major Depressive DisorderNCT06211140
Transcranial Alternating Current Stimulation (tACS) on Serotonin-1A Receptor in Depression
A study testing tACS in people with Major Depressive Disorder, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study will apply a comprehensive tools that integrates neuroimaging, psychological evaluation, and sleep monitoring through 18F-MPPF PET/MR, neuropsychological tests, and polysomnography (PSG) to explore the neurobiological mechanisms underlying transcranial alternating current stimulation (tACS) for depressive… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 May 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To undergo PET/MR examinations.
- Be matched with the patient group regarding age, sex, and educational level.
Who cannot join
- Unable to do PET/MR examinations.
- Have secondary insomnia disorders, anxiety disorders, or depressive disorders caused by physical illnesses.
- Severe or unstable organic diseases.
- Pregnant or lactating women or those planning a pregnancy in the near future.
- Alcohol or substance dependence or abuse within the past year.
- Received electroconvulsive therapy or transcranial magnetic stimulation in the month preceding enrollment.
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- Skin damage at the electrode placement site or those allergic to electrode gel or adhesives.
- Participated in any other clinical trials within the month before baseline.
- Any inappropriate conditions considered by the study group.
- Those who are enrolled in other clinical studies.
- The inappropriate conditions considered by the study group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Wenfeng Zhao, MD, +8613051118863, fengfeng_zw@ccmu.edu.cn
Jie Lu, MD & PhD
About this study
Official title: Effect of Transcranial Alternating Current Stimulation (tACS) on Serotonin-1A Receptor in Patients With Major Depressive Disorder
This study will apply a comprehensive tools that integrates neuroimaging, psychological evaluation, and sleep monitoring through 18F-MPPF PET/MR, neuropsychological tests, and polysomnography (PSG) to explore the neurobiological mechanisms underlying transcranial alternating current stimulation (tACS) for depressive disorders, mainly focusing on the serotonergic system revealed by Serotonin-1A (5-HT1A) receptor.
Read the detailed description
5-HT1A receptor appears to be significantly involved in the effectiveness of electroconvulsive therapy (ECT). Like alternating current in ECT, tACS also applies alternating current to intervene in neuropsychiatric disorders. We previously found that tACS with large current, such as 15 mA, via the forehead and bilateral mastoids can improve depressive symptoms. However, the underlying mechanism of 15 mA tACS in depression remains unclear. We propose a scientific hypothesis that 15 mA tACS may increase hippocampal 5- HT1A receptors, then to reduce depression in depressive patients. Meanwhile, 15 mA tACS may increase the whole-brain functional connectivity with the hippocampus as the seed point. This study will utilize a multimodal data through 18F-MPPF PET/MR, including MPPF metabolism, resting-state fMRI, DTI, and 3D-T1 structural images. By observing the alterations of 5-HT1A receptor and the functional network between MDD patients and healthy controls, and between the pre- and post-tACS intervention in MDD patients, our aims to explore the effect of tACS on the serotonergic system in depression.
- Conditions
- Major Depressive Disorder
- Being tested
- tACS, Control
- Keywords
- Major Depressive Disorder, Depression, tACS, 5-HT
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
tACS in 4 weeks, once per weekday for 40 minutes each, 20 sessions. The treatment group will receive transcranial alternating current stimulation at a gamma frequency (77.5Hz) with a peak amplitude of 15mA.
ControlOther
Without the tACS stimulation in this group.
| Study group | Role | What they receive |
|---|---|---|
| Depressive disorders | Experimental | Three conductive electrodes will be placed overhead. Based on the 10/20 international placement system, a 4.45 x 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 x 3.81 cm electrodes are placed on the mastoid region of each side.
The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. It is a square-wave with an average amplitude of 15 mA and is equally distributed from the frontal region to the mastoid areas (amplitudes are reported as zero-to-peak).
All participants with major depression disorder will receive a total of 20 sessions in four weeks, once daily on weekdays, with tACS stimulation at 77.5 Hz and 15 mA.
From Monday to Friday, each session will last 40 min at a fixed daytime interval. Receives: Device: tACS |
| Healthy controls | Other | Without the tACS stimulation in this group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in quantitative MPPF values before and after the tACS intervention.
Twenty patients with depressive disorders will receive 18F-MPPF PET/MR imaging before and after the tACS intervention. MPPF metabolism values in different brain regions will be calculated.
A comparative analysis will be then performed between the baseline and post-treatment in patients with depressive disorders.
Measured: baseline (before the tACS intervention), 4 weeks (after the tACS intervention)
Secondary outcomes (7)
The changes in scores for 17-item Hamilton Depression Rating Scale (HAMD-17) before and after the tACS intervention.
HAMD-17 will be assessed before and after the tACS intervention in twenty patients with depressive disorders. HAMD-17 scores range from 0 to 52, with higher scores indicating more depression, a score of 24 or more indicates severe depression.
Measured: baseline, 4 weeks
The changes in scores for Hamilton Anxiety Rating Scale (HAMA) before and after the tACS intervention.
HAMA evaluation will be conducted before and after the tACS intervention in twenty patients with depressive disorders. HAMA scores range from 0 to 56, with higher scores indicating more anxiety, a score of 29 or more indicates severe anxiety.
Measured: baseline, 4 weeks
The changes in scores for Generalized Anxiety Disorder-7 item (GAD-7) before and after the tACS intervention.
GAD-7 total score range 0 to 21. A score of 10 or higher means significant anxiety is present. Score over 15 are severe.
Measured: baseline, 4 weeks
The changes in scores for Pittsburgh Sleep Quality Index (PSQI) before and after the tACS intervention.
PSQI score ranges 0 to 21, a score of 8 or more indicates insomnia.
Measured: baseline, 4 weeks
The changes in scores for Insomnia Severity Index (ISI) before and after the tACS intervention.
ISI total score is 0 to 28, a total score of 0-7 indicates 'no clinically signifi cant insomnia', 8-14 means 'subthreshold insomnia', 15-21 is 'clinical insomnia (moderate severity)', and 22-28 means 'clinical insomnia (severe)'.
Measured: baseline, 4 weeks
Cognitive changes will be assessed using the Montreal Cognitive Assessment (MoCA) before and after the tACS intervention in depression.
MoCA total score ranges 0 to 30. If the length of education is less than 12 years, 1 point will be added, with a maximum score of 30 points. A score of 26 is considered normal.
Measured: baseline, 4 weeks
Cognitive changes will be assessed using the Mini-Mental State Examination (MMSE) before and after the tACS intervention in depression.
MMSE total score is from 0 to 30. The criteria on cognitive impairment in Chinese as follows: the illiterate ≤ 17 points, the primary school ≤ 20 points, and the middle school or above ≤ 24 points
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start31 Jan 2024 (estimated)
- Primary completion20 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment; Non-Randomized; Open-label
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211140
- Sponsor's protocol ID
- tACS-MDD
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Alternating Current Stimulation (tACS) on Serotonin-1A Receptor in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06211140
- Acronym / sponsor ID
- tACS-MDD
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depression, tACS, 5-HT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 18 Jan 2024 (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.
This study will apply a comprehensive tools that integrates neuroimaging, psychological evaluation, and sleep monitoring through 18F-MPPF PET/MR, neuropsychological tests, and polysomnography (PSG) to explore the neurobiological mechanisms underlying transcranial alternating current stimulation (tACS) for depressive disorders, mainly focusing on the serotonergic system revealed by Serotonin-1A (5-HT1A) receptor.
Detailed description
5-HT1A receptor appears to be significantly involved in the effectiveness of electroconvulsive therapy (ECT). Like alternating current in ECT, tACS also applies alternating current to intervene in neuropsychiatric disorders. We previously found that tACS with large current, such as 15 mA, via the forehead and bilateral mastoids can improve depressive symptoms. However, the underlying mechanism of 15 mA tACS in depression remains unclear. We propose a scientific hypothesis that 15 mA tACS may increase hippocampal 5- HT1A receptors, then to reduce depression in depressive patients. Meanwhile, 15 mA tACS may increase the whole-brain functional connectivity with the hippocampus as the seed point. This study will utilize a multimodal data through 18F-MPPF PET/MR, including MPPF metabolism, resting-state fMRI, DTI, and 3D-T1 structural images. By observing the alterations of 5-HT1A receptor and the functional network between MDD patients and healthy controls, and between the pre- and post-tACS intervention in MDD patients, our aims to explore the effect of tACS on the serotonergic system in depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment; Non-Randomized; Open-label
| Arm | Type | Receives |
|---|---|---|
| Depressive disorders | Experimental | Device: tACSThree conductive electrodes will be placed overhead. Based on the 10/20 international placement system, a 4.45 x 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 x 3.81 cm electrodes are placed on the mastoid region of each side. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. It is a square-wave with an average amplitude of 15 mA and is equally distributed from the frontal region to the mastoid areas (amplitudes are reported as zero-to-peak). All participants with major depression disorder will receive a total of 20 sessions in four weeks, once daily on weekdays, with tACS stimulation at 77.5 Hz and 15 mA. From Monday to Friday, each session will last 40 min at a fixed daytime interval. |
| Healthy controls | Other | Other: ControlWithout the tACS stimulation in this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To undergo PET/MR examinations.
- Be matched with the patient group regarding age, sex, and educational level.
Key exclusion criteria (11 listed)
- Unable to do PET/MR examinations.
- Have secondary insomnia disorders, anxiety disorders, or depressive disorders caused by physical illnesses.
- Severe or unstable organic diseases.
- Pregnant or lactating women or those planning a pregnancy in the near future.
- Alcohol or substance dependence or abuse within the past year.
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 |
|---|---|---|
| tACStACS in 4 weeks, once per weekday for 40 minutes each, 20 sessions. The treatment group will receive transcranial alternating current stimulation at a gamma frequency (77.5Hz) with a peak amplitude of 15mA. | Device | Depressive disorders |
| ControlWithout the tACS stimulation in this group. | Other | Healthy controls |
Primary outcome
The changes in quantitative MPPF values before and after the tACS intervention.
Time frame: baseline (before the tACS intervention), 4 weeks (after the tACS intervention)
Twenty patients with depressive disorders will receive 18F-MPPF PET/MR imaging before and after the tACS intervention. MPPF metabolism values in different brain regions will be calculated. A comparative analysis will be then performed between the baseline and post-treatment in patients with depressive disorders.
7 secondary outcomes
The changes in scores for 17-item Hamilton Depression Rating Scale (HAMD-17) before and after the tACS intervention.
Time frame: baseline, 4 weeks
The changes in scores for Hamilton Anxiety Rating Scale (HAMA) before and after the tACS intervention.
Time frame: baseline, 4 weeks
The changes in scores for Generalized Anxiety Disorder-7 item (GAD-7) before and after the tACS intervention.
Time frame: baseline, 4 weeks
The changes in scores for Pittsburgh Sleep Quality Index (PSQI) before and after the tACS intervention.
Time frame: baseline, 4 weeks
The changes in scores for Insomnia Severity Index (ISI) before and after the tACS intervention.
Time frame: baseline, 4 weeks
Cognitive changes will be assessed using the Montreal Cognitive Assessment (MoCA) before and after the tACS intervention in depression.
Time frame: baseline, 4 weeks
Cognitive changes will be assessed using the Mini-Mental State Examination (MMSE) before and after the tACS intervention in depression.
Time frame: baseline, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS in people with Major Depressive Disorder, run by Xuanwu Hospital, Beijing 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenfeng Zhao, MD (+8613051118863, fengfeng_zw@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in quantitative MPPF values before and after the tACS intervention. (time frame: baseline (before the tACS intervention), 4 weeks (after the tACS intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024.