Treatment Resistant DepressionrTMSNCT03991572
rTMS Intervention on Motivational Anhedonia of Treatment Resistant Depression and Brian Network Mechanism
A study testing repeated transcranial magnetic stimulation with real coil in people with Treatment Resistant Depression and Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
Trial summary
Study of individualized accurate targeting rTMS intervention on motivational anhedonia of treatment resistant depression and brain network mechanism Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Treatment Resistant Depression, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging
- What is being tested?
- repeated transcranial magnetic stimulation with real coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2021
- 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 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- History of significant head trauma or neurological disorders.
- Alcohol or drug abuse.
- Focal brain lesions.
- History of seizure.
- First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
- Significant unstable medical condition.
Show all 12Show fewer
- Recent aggression or other forms of behavioral dyscontrol.
- Left-handedness.
- Pregnancy.
- Current alcohol or drug abuse
- Inability to provide informed consent.
- Patients with contraindications or factors affecting imaging quality, such as pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal denture.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230032
Fengqiong Yu, yufengqin1@163.com
About this study
Official title: Study of Individualized Accurate Targeting rTMS Intervention on Motivational Anhedonia of Treatment Resistant Depression and Brain Network Mechanism
Study of individualized accurate targeting rTMS intervention on motivational anhedonia of treatment resistant depression and brain network mechanism
Read the detailed description
Before treatment, Magnetic resonance images of each participant were acquired from scanner of the same type (3.0T, Discovery GE750w). As the key role of nucleus accumbens (NACC, -7.5, 5.5, 9) in anhedonia, the accurate target of left dlPFC was defined as the strongest functional connectivity with NACC. Each treatment session was under neuronavigation with a Visor neuronavigation system (ANT Neuro, Enschede, Netherlands) for coil positioning.
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to real group or sham group by coin toss. A threshold of 3 points on the Hamilton Depression scale has been specified by the National Institute for Health and Care Excellence to determine a clinically meaningful difference between active pharmacotherapy and placebo. We plan to enroll minimum total sample size of 29 participants in real and sham group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. The participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to the allocated condition and allocation parameters. Only the rTMS administrators had access to the randomization list. They had minimal contact with the patients, and no role in assessing depression. Each patient would be treated for continuous 15 days by rTMS.
Before the rTMS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale. The neuroimaging data was collected using functional magnetic resonance imaging scan in multimodalities, resting electroencephalography, and event-related potentials during monetary incentive delay task, and Iowa-gambling test. The participants had also received a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems). After the last treatment, the same scales and neuroimaging scan were used again to assess the treatment effect of the rTMS and the underlying brain mechanism. Each participant was interviewed in detail about the adverse event of the rTMS intervention during the past 15 days. A month after the last treatment, each participant received follow-up visit by telephone to access the persistent effect of the intervention. Every participant should take part in the study in voluntary and sign an informed consent form before the study.
- Conditions
- Treatment Resistant Depression, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Event-Related Potentials
- Being tested
- repeated transcranial magnetic stimulation with real coil, repeated transcranial magnetic stimulation with sham coil
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated transcranial magnetic stimulation with real coilDevice
repeated transcranial magnetic stimulation with real coil is a noninvasive technique to activate and modify the activity of the neurons
repeated transcranial magnetic stimulation with sham coilDevice
repeated transcranial magnetic stimulation with sham coil is a placebo
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Active comparator | The Real Stimulation of rTMS 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 MRI dataset should be acquired before the first rTMS session and after the last rTMS session. Receives: Device: repeated transcranial magnetic stimulation with real coil |
| Sham Stimulation | Sham comparator | The procedure of Sham Stimulation protocol was performed by a placebo coil,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) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session. Receives: Device: repeated transcranial magnetic stimulation with sham coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hamilton Depression Scale
The participants' depression symptom assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale change from baseline after the treatment.
Measured: baseline;15 day post-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.
Measured: baseline;15 day post-treatment
Secondary outcomes (3)
The change from baseline in behavioral results of Monetary Incentive Delay task
The motivational anhedonia assessed by accuracy and response time in Monetary Incentive Delay task
Measured: baseline; 15 day post-treatment change from baseline after the treatment.
The change from baseline in event-related brain potentials during the monetary incentive delay task
The amplitudes of brain potentials of contingent negative variation, P3 and Feed-back negativity assessed by event-related brain potentials methods change from baseline after the treatment.
Measured: baseline; 15 day post-treatment
The change from baseline in neuroimaging results of functional magnetic resonance imaging scan in multimodalities
The activation of nucleus accumbens, dorsal lateral prefrontal cortex and the functional connection these brain area assessed by functional magnetic resonance imaging scan in multimodalities change from baseline after the treatment.
Measured: baseline; 15 day post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 Treatment Resistant 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
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, MD, Study chair, Anhui Medical UniversityFengqiong Yu, MD, Study director, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991572
- Sponsor's protocol ID
- FYu
- Acronym
- rTMS
- Status last verified
- Jun 2019
- First submitted
- 22 Apr 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, He K, Chen T, Shi B, Yang J, Geng W, Zhang L, Zhu C, Ji G, Tian Y, Bai T, Dong Y, Luo Y, Wang K, Yu F. Therapeutic efficacy of connectivity-directed transcranial magnetic stimulation on anticipatory anhedonia. Depress Anxiety. 2021 Sep;38(9):972-984. doi: 10.1002/da.23188. Epub 2021 Jun 22.
PubMed 34157193
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Individualized Accurate Targeting rTMS Intervention on Motivational Anhedonia of Treatment Resistant Depression and Brain Network Mechanism
- ClinicalTrials.gov ID
- NCT03991572
- Acronym / sponsor ID
- rTMS / FYu
- Conditions
- Treatment Resistant Depression, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Event-Related Potentials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Jun 2019 (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 of individualized accurate targeting rTMS intervention on motivational anhedonia of treatment resistant depression and brain network mechanism
Detailed description
Before treatment, Magnetic resonance images of each participant were acquired from scanner of the same type (3.0T, Discovery GE750w). As the key role of nucleus accumbens (NACC, -7.5, 5.5, 9) in anhedonia, the accurate target of left dlPFC was defined as the strongest functional connectivity with NACC. Each treatment session was under neuronavigation with a Visor neuronavigation system (ANT Neuro, Enschede, Netherlands) for coil positioning.
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to real group or sham group by coin toss. A threshold of 3 points on the Hamilton Depression scale has been specified by the National Institute for Health and Care Excellence to determine a clinically meaningful difference between active pharmacotherapy and placebo. We plan to enroll minimum total sample size of 29 participants in real and sham group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. The participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to the allocated condition and allocation parameters. Only the rTMS administrators had access to the randomization list. They had minimal contact with the patients, and no role in assessing depression. Each patient would be treated for continuous 15 days by rTMS.
Before the rTMS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, Dimensional Anhedonia Rating Scale, the Motivation and Pleasure Scale. The neuroimaging data was collected using functional magnetic resonance imaging scan in multimodalities, resting electroencephalography, and event-related potentials during monetary incentive delay task, and Iowa-gambling test. The participants had also received a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems). After the last treatment, the same scales and neuroimaging scan were used again to assess the treatment effect of the rTMS and the underlying brain mechanism. Each participant was interviewed in detail about the adverse event of the rTMS intervention during the past 15 days. A month after the last treatment, each participant received follow-up visit by telephone to access the persistent effect of the intervention. Every participant should take part in the study in voluntary and sign an informed consent form before the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation | Active comparator | Device: repeated transcranial magnetic stimulation with real coilThe Real Stimulation of rTMS 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 MRI dataset should be acquired before the first rTMS session and after the last rTMS session. |
| Sham Stimulation | Sham comparator | Device: repeated transcranial magnetic stimulation with sham coilThe procedure of Sham Stimulation protocol was performed by a placebo coil,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) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- History of significant head trauma or neurological disorders.
- Alcohol or drug abuse.
- Focal brain lesions.
- History of seizure.
- First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
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 stimulation with real coilrepeated transcranial magnetic stimulation with real coil is a noninvasive technique to activate and modify the activity of the neurons | Device | Real Stimulation |
| repeated transcranial magnetic stimulation with sham coilrepeated transcranial magnetic stimulation with sham coil is a placebo | Device | Sham Stimulation |
Primary outcome
Change from baseline in Hamilton Depression Scale
Time frame: baseline;15 day post-treatment
The participants' depression symptom assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale change from baseline after the treatment.
Change from baseline in Motivation and Pleasure Scale
Time frame: baseline;15 day post-treatment
The severity of participants' anhedonia assessed by the Motivation and Pleasure Scale change from baseline after the treatment.
3 secondary outcomes
The change from baseline in behavioral results of Monetary Incentive Delay task
Time frame: baseline; 15 day post-treatment change from baseline after the treatment.
The change from baseline in event-related brain potentials during the monetary incentive delay task
Time frame: baseline; 15 day post-treatment
The change from baseline in neuroimaging results of functional magnetic resonance imaging scan in multimodalities
Time frame: baseline; 15 day post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 34157193Wang X, He K, Chen T, Shi B, Yang J, Geng W, Zhang L, Zhu C, Ji G, Tian Y, Bai T, Dong Y, Luo Y, Wang K, Yu F. Therapeutic efficacy of connectivity-directed transcranial magnetic stimulation on anticipatory anhedonia. Depress Anxiety. 2021 Sep;38(9):972-984. doi: 10.1002/da.23188. Epub 2021 Jun 22.
Related trials for Treatment Resistant Depression
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
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, MD study chair
Anhui Medical University
Fengqiong Yu, MD study director
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 with real coil in people with Treatment Resistant Depression and Transcranial Magnetic Stimulation, 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 0 inclusion and 12 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 19 Jun 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengqiong Yu, MD (0086055115955155423, yufengqin1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hamilton Depression Scale (time frame: baseline;15 day post-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?
On the ClinicalTrials.gov record for NCT03991572, 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 19 Jun 2019.