DepressionNCT06552026
Intermittent Theta Burst Stimulation on Anhedonia in Depression
A study testing repeated transcranial magnetic stimulation in people with Depression and Electroencephalography, run by Anhui Medical University at 1 site in China.
Trial summary
Study comparing the efficacy of two TMS patterns (intermittent theta-burst stimulation, iTBS, and repetitive transcranial magnetic stimulation, rTMS) in treating anhedonia and their associated brain network mechanisms. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Depression, Electroencephalography, Transcranial Magnetic Stimulation
- What is being tested?
- repeated transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2020to 14 Dec 2022
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed by more than two clinical psychiatrists, using the DSM-5 diagnostic criteria for depression.
- the Self-Report Apathy Evaluation Scale score was more than 37 and the The Temporal Experience of Pleasure Scale score was less than 76.
- consistent medical therapeutic plan for ≥4 weeks or no history of antidepressant drugs before rTMS treatment.
- aged between 16 and 50 years old.
Who cannot join
- participants with unstable physical conditions, pregnancy or those that were breastfeeding.
- metal implants on or inside the head. increased intracranial pressure from cerebral infarction or brain injury. a history of substance abuse or major psychiatric diseases other than depression and current use of psychoactive drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Theta Burst Stimulation on Anhedonia of Treatment Resistant Depression and Brian Network Mechanism
Study comparing the efficacy of two TMS patterns (intermittent theta-burst stimulation, iTBS, and repetitive transcranial magnetic stimulation, rTMS) in treating anhedonia and their associated brain network mechanisms.
Read the detailed description
Anhedonia is a core feature in major depressive disorders, severely affecting up to 70% patients and remaining untreated after traditional antidepressants therapies. In previous work, the investigators provided clinical evidence for the therapeutic efficacy of personalized rTMS in treating anhedonia. However, the key practical question is whether personalized, connectivity-guided iTBS performs comparably to the existing standard rTMS about the clinical efficacy.
This study was designed as a double-blind controlled trial to investigate the intervention effect of iTBS stimulation on anhedonia in depressed patients. 33 subjects were included, 17 participated in conventional 10 Hz-rTMS treatment and 16 in iTBS treatment. Using the subjects' MRI imaging data of the nucleus accumbens (NAcc) as a seed point, individualized left dorsolateral prefrontal cortex (lDLPFC) targets were calculated from brain imaging data. Patients received once-daily treatment for 15 days.
Clinical symptoms, behavioral and EEG assessments were performed before and after treatment. Clinical assessments included The Hamilton Anxiety Scale (HAMA), the Hamilton Depression Rating Scale (HAMD), the Beck Depression Inventory (BDI), the Temporal Experience of Pleasure Scale (TEPS), and Apathy Evaluation Scale (AES); behavioral and EEG data were collected by the Monetary paradigm. One month after the end of the intervention, follow-up BDI, TEPS, and AES symptom data were collected by electronic scales. This study focused on the analysis of scale, behavioral, and EEG data of subjects .
- Being tested
- repeated transcranial magnetic stimulation
- Keywords
- anhedonia; intermittent theta burst stimulation
- Medical subject headings
- Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated transcranial magnetic stimulationDevice
repetitive transcranial magnetic stimulation by use of high-frequency (10 Hz) left-side DLPFC stimulation is currently widely used in the treatment of depression17.Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered with shorter duration of stimulation sessions and apparent efficacy at lower stimulation intensities18. Both 10 Hz and intermittent theta burst stimulation pulses have an excitatory effect on cortical excitability
| Study group | Role | What they receive |
|---|---|---|
| iTBS stimulation | Experimental | The iTBS stimulation lasted 3 min 9 s and delivered at triplet 50 Hz bursts, repeated at 5 Hz with 2s on, 8 s off, 600 pulses per session at 80% of the rest motor threshold(RMT) . Behavior and EEG dataset should be acquired before the first iTBS session and after the last iTBS session. Receives: Device: repeated transcranial magnetic stimulation |
| 10 Hz-rTMS stimulation | Active comparator | The rTMS stimulation lasted 25 mins and delivered at 10 Hz with 1s duration,4s rest, a total of 3000 pulses at 100% of the rest motor threshold(RMT) . Behavior and EEG dataset should be acquired before the first rTMS session and after the last rTMS session. Receives: Device: repeated transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression symptoms severity
The Hamilton depression rating scale-17 items (HAMD-17) to clinically assess severity of depression. The curative effects of the treatment were classified according to the reduction in HAMD. Response was defined as ≥50% symptom reduction from pre-to post-treatment with a HAMD score; remission criteria were set at a post-treatment score ≤7 for HAMD.
Measured: Baseline;15 days after treatment
Change from baseline in Motivation and Pleasure Scale
Change from baseline in Motivation and Pleasure Scale The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.
Measured: Baseline;15 days after treatment
Secondary outcomes (1)
The alteration from baseline in electrophysiological source imaging results in multimodalities
The activation of nucleus accumbens, dorsal lateral prefrontal cortex and the functional connection these brain area assessed by source-level resting-state EEG connectivity in multimodalities change from baseline after the treatment.
Measured: Baseline;15 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start12 Aug 2020
- Primary completion10 Oct 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Model description
- a parallel two-arm model ,Participants were randomized to two groups by coin toss, and delivered rTMS or iTBS over the lDLPFC-NAcc once daily for 15 consecutive days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengqiong Yu, Anhui Medical University
- Investigators
- Kai Wang, PHD, Study chair, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552026
- Sponsor's protocol ID
- Y&F
- Status last verified
- Aug 2024
- First submitted
- 22 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Theta Burst Stimulation on Anhedonia of Treatment Resistant Depression and Brian Network Mechanism
- ClinicalTrials.gov ID
- NCT06552026
- Acronym / sponsor ID
- Y&F
- Keywords
- anhedonia; intermittent theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 13 Aug 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.
Study comparing the efficacy of two TMS patterns (intermittent theta-burst stimulation, iTBS, and repetitive transcranial magnetic stimulation, rTMS) in treating anhedonia and their associated brain network mechanisms.
Detailed description
Anhedonia is a core feature in major depressive disorders, severely affecting up to 70% patients and remaining untreated after traditional antidepressants therapies. In previous work, the investigators provided clinical evidence for the therapeutic efficacy of personalized rTMS in treating anhedonia. However, the key practical question is whether personalized, connectivity-guided iTBS performs comparably to the existing standard rTMS about the clinical efficacy.
This study was designed as a double-blind controlled trial to investigate the intervention effect of iTBS stimulation on anhedonia in depressed patients. 33 subjects were included, 17 participated in conventional 10 Hz-rTMS treatment and 16 in iTBS treatment. Using the subjects' MRI imaging data of the nucleus accumbens (NAcc) as a seed point, individualized left dorsolateral prefrontal cortex (lDLPFC) targets were calculated from brain imaging data. Patients received once-daily treatment for 15 days.
Clinical symptoms, behavioral and EEG assessments were performed before and after treatment. Clinical assessments included The Hamilton Anxiety Scale (HAMA), the Hamilton Depression Rating Scale (HAMD), the Beck Depression Inventory (BDI), the Temporal Experience of Pleasure Scale (TEPS), and Apathy Evaluation Scale (AES); behavioral and EEG data were collected by the Monetary paradigm. One month after the end of the intervention, follow-up BDI, TEPS, and AES symptom data were collected by electronic scales. This study focused on the analysis of scale, behavioral, and EEG data of subjects .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a parallel two-arm model ,Participants were randomized to two groups by coin toss, and delivered rTMS or iTBS over the lDLPFC-NAcc once daily for 15 consecutive days.
| Arm | Type | Receives |
|---|---|---|
| iTBS stimulation | Experimental | Device: repeated transcranial magnetic stimulationThe iTBS stimulation lasted 3 min 9 s and delivered at triplet 50 Hz bursts, repeated at 5 Hz with 2s on, 8 s off, 600 pulses per session at 80% of the rest motor threshold(RMT) . Behavior and EEG dataset should be acquired before the first iTBS session and after the last iTBS session. |
| 10 Hz-rTMS stimulation | Active comparator | Device: repeated transcranial magnetic stimulationThe rTMS stimulation lasted 25 mins and delivered at 10 Hz with 1s duration,4s rest, a total of 3000 pulses at 100% of the rest motor threshold(RMT) . Behavior and EEG dataset should be acquired before the first rTMS session and after the last rTMS session. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- diagnosed by more than two clinical psychiatrists, using the DSM-5 diagnostic criteria for depression.
- the Self-Report Apathy Evaluation Scale score was more than 37 and the The Temporal Experience of Pleasure Scale score was less than 76.
- consistent medical therapeutic plan for ≥4 weeks or no history of antidepressant drugs before rTMS treatment.
- aged between 16 and 50 years old.
Key exclusion criteria (2 listed)
- participants with unstable physical conditions, pregnancy or those that were breastfeeding.
- metal implants on or inside the head. increased intracranial pressure from cerebral infarction or brain injury. a history of substance abuse or major psychiatric diseases other than depression and current use of psychoactive drug.
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 |
|---|---|---|
| repeated transcranial magnetic stimulationrepetitive transcranial magnetic stimulation by use of high-frequency (10 Hz) left-side DLPFC stimulation is currently widely used in the treatment of depression17.Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that can be delivered with shorter duration of stimulation sessions and apparent efficacy at lower stimulation intensities18. Both 10 Hz and intermittent theta burst stimulation pulses have an excitatory effect on cortical excitability | Device | 10 Hz-rTMS stimulation, iTBS stimulation |
Primary outcome
Change in depression symptoms severity
Time frame: Baseline;15 days after treatment
The Hamilton depression rating scale-17 items (HAMD-17) to clinically assess severity of depression. The curative effects of the treatment were classified according to the reduction in HAMD. Response was defined as ≥50% symptom reduction from pre-to post-treatment with a HAMD score; remission criteria were set at a post-treatment score ≤7 for HAMD.
Change from baseline in Motivation and Pleasure Scale
Time frame: Baseline;15 days after treatment
Change from baseline in Motivation and Pleasure Scale The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.
1 secondary outcome
The alteration from baseline in electrophysiological source imaging results in multimodalities
Time frame: Baseline;15 days after treatment
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 13 Aug 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.
Kai Wang, PHD study chair
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated transcranial magnetic stimulation in people with Depression and Electroencephalography, run by Anhui Medical 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 4 inclusion and 2 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 13 Aug 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?
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?
Change in depression symptoms severity (time frame: Baseline;15 days after treatment). The study lists 2 primary outcomes in all. 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 13 Aug 2024.