Obsessive-Compulsive DisorderNCT03393078
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Obsessive Compulsive Disease
A study testing transcranial magnetic stimulation with real coil in people with Obsessive-Compulsive Disorder and Transcranial Magnetic Stimulation, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the treatment effect of repetitive transcranial magnetic stimulation on Obsessive-compulsive disorder, and the underlying neural mechanism by functional MRI. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging
- What is being tested?
- 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
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Dec 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients met diagnostic criteria for obsessive-compulsive disorder using The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)，confirmed by two clinical psychiatrist.
- Y-BOCS total severity scores ≥16（Simple forced obsessions or compulsions ≥ 10），HAMA-14 scores < 14，HAMD-17 scores < 17； Raven's Standard Progressive Matrices（SPM） up to normal levels.
- After more than one anti-OCD drugs treatment for 8-10 weeks, no significant improvement in symptoms.
- Voluntarily participated and cooperated with the experiment.
Who cannot join
- History of significant head trauma or neurological disorders. Alcohol or drug abuse. Organic brain defects on T1 or T2 images. History of seizures or unexplained loss of consciousness. Family history of medication refractory epilepsy. recent aggression or other forms of behavioral dyscontrol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Brain Network Mechanism for Individualized Accurate Target Positioning rTMS Treatment on Obsessive Compulsive Disorder
To investigate the treatment effect of repetitive transcranial magnetic stimulation on Obsessive-compulsive disorder, and the underlying neural mechanism by functional MRI.
Read the detailed description
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 rTMS group and the sham group. There are about 30 patients in each group. For the first 30 patients, allocation was by coin toss. For the subsequent 30 patients, allocation was according to computer generated random numbers. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the Yale-Brown Obsessive Compulsive Scale(Y-BOCS). Each patient would be treated for continuous 15 days by rTMS.
Before the rTMS treatment, Y-BOCS, Padua Inventory-Washington State University Revision(PI-WSUR), Hamilton Depression Scale(HAMD-17) and Hamilton Anxiety Scale (HAMA-14) were obtained by a trained investigator to assess baseline severity of and other symptoms. The patients had receiving a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems, anxiety and depressive symptoms in daily life), magnetic resonance imaging scan in multimodalities, electroencephalography (EEG), event-related potentials during stop signal test and task switch paradigm record.
After the last treatment, Y-BOCS, PI-WSUR, HAMD-17 and HAMA-14 were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.
A month after the last treatment, participants were interviewed to obtain the Y-BOCS, PI-WSUR, HAMD-17 and HAMA-14. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.
- Conditions
- Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Event-Related Potentials
- Being tested
- transcranial magnetic stimulation with real coil, transcranial magnetic stimulation with sham coil
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulation with real coilDevice
TMS with real coil is a noninvasive technique to activate and modify the activity of the neurons
transcranial magnetic stimulation with sham coilDevice
TMS with sham coil is a placebo
| Study group | Role | What they receive |
|---|---|---|
| Real Stimulation | Active comparator | The repetition transcranial magnetic stimulation(rTMS) lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 110% of the rest motor threshold (RMT) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session. Receives: Device: transcranial magnetic stimulation with real coil |
| Sham Stimulation | Sham comparator | The procedure of this protocol was performed by a placebo coil, lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 110% of the rest motor threshold (RMT). No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first rTMS session and after the last rTMS session. Receives: Device: transcranial magnetic stimulation with sham coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
The Yale-Brown Obsessive Compulsive Scale is a test to rate the severity of obsessive-compulsive disorder symptoms, which measures obsessions separately from compulsions. The scale includes 10 items, the first 5 items are evaluated obsessions, the rest are assessments compulsions. Each item 0-4 points, a total of 40 points. The lower the score, the better the outcome.
Measured: up to 1 months
Secondary outcomes (5)
Stop-Signal Task
Stop-Signal Task is a typical paradigm for measuring response inhibition and contains three indicators: Stop-signal reaction time (SSRT), the lower the SSRT value, the better the inhibition of reaction; Go task reaction time (GORT), GoRT is usually used in combination with SSRT to reveal the impaired of response inhibition; Stop-signal delays (SSD), SSD value increases, more difficult to inhibit successfully.
Measured: pre-treatment; 1 day post-treatment
Task Switch
Task Switch is a paradigm for measuring cognitive flexibility, which involves the ability to unconsciously shift attention between one task and another and contains two indicators: task repeat and task switch.
Measured: pre-treatment; 1 day post-treatment
Wisconsin CardSorting Test
The Wisconsin Card Sorting Test is a cognitive neuropsychological test, used to determine the abilities of human abstraction, concept formation, working memory and cognitive flexibility. Test measures a total of five indicators: Correct Response, Total Errors, Perseverative Responses, Perseverative Errors and Trials to complete 1st cat.
Measured: pre-treatment; 1 day post-treatment
Hanoi Tower
Hanoi Tower is a test of planning and problem solving, that contains four indicators: total movement, Latency, 1st move reaction time and total reaction time.
Measured: pre-treatment; 1 day post-treatment
Symptom improvement assessed by the Padua Inventory-Washington State University Revision
The Padua Inventory-Washington State University Revision is a self-rating scale for the severity of symptoms，that contains 5 subscales, 35 items. Each item 0-4 points, a total of 140 points. The lower the score, the better the outcome.
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Aug 2017
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunyan Zhu, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393078
- Sponsor's protocol ID
- AnhuiMU
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2017
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Brain Network Mechanism for Individualized Accurate Target Positioning rTMS Treatment on Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT03393078
- Acronym / sponsor ID
- AnhuiMU
- Conditions
- Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Event-Related Potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 8 Jan 2018 (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.
To investigate the treatment effect of repetitive transcranial magnetic stimulation on Obsessive-compulsive disorder, and the underlying neural mechanism by functional MRI.
Detailed description
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 rTMS group and the sham group. There are about 30 patients in each group. For the first 30 patients, allocation was by coin toss. For the subsequent 30 patients, allocation was according to computer generated random numbers. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing the Yale-Brown Obsessive Compulsive Scale(Y-BOCS). Each patient would be treated for continuous 15 days by rTMS.
Before the rTMS treatment, Y-BOCS, Padua Inventory-Washington State University Revision(PI-WSUR), Hamilton Depression Scale(HAMD-17) and Hamilton Anxiety Scale (HAMA-14) were obtained by a trained investigator to assess baseline severity of and other symptoms. The patients had receiving a battery measure of neuropsychological tests (standardized tests to investigate their cognitive problems, anxiety and depressive symptoms in daily life), magnetic resonance imaging scan in multimodalities, electroencephalography (EEG), event-related potentials during stop signal test and task switch paradigm record.
After the last treatment, Y-BOCS, PI-WSUR, HAMD-17 and HAMA-14 were obtained, as well as the Global Index of Safety to assess adverse events of the treatment. Patients were instructed to focus their answers on the past 15 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.
A month after the last treatment, participants were interviewed to obtain the Y-BOCS, PI-WSUR, HAMD-17 and HAMA-14. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation | Active comparator | Device: transcranial magnetic stimulation with real coilThe repetition transcranial magnetic stimulation(rTMS) lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 110% of the rest motor threshold (RMT) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session. |
| Sham Stimulation | Sham comparator | Device: transcranial magnetic stimulation with sham coilThe procedure of this protocol was performed by a placebo coil, lasted 30 mins and delivered at 1 Hz with 1s duration, a total of 1800 pulses at 110% of the rest motor threshold (RMT). No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first rTMS session and after the last rTMS session. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients met diagnostic criteria for obsessive-compulsive disorder using The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)，confirmed by two clinical psychiatrist.
- Y-BOCS total severity scores ≥16（Simple forced obsessions or compulsions ≥ 10），HAMA-14 scores < 14，HAMD-17 scores < 17； Raven's Standard Progressive Matrices（SPM） up to normal levels.
- After more than one anti-OCD drugs treatment for 8-10 weeks, no significant improvement in symptoms.
- Voluntarily participated and cooperated with the experiment.
Key exclusion criteria (1 listed)
- History of significant head trauma or neurological disorders. Alcohol or drug abuse. Organic brain defects on T1 or T2 images. History of seizures or unexplained loss of consciousness. Family history of medication refractory epilepsy. recent aggression or other forms of behavioral dyscontrol.
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 |
|---|---|---|
| transcranial magnetic stimulation with real coilTMS with real coil is a noninvasive technique to activate and modify the activity of the neurons | Device | Real Stimulation |
| transcranial magnetic stimulation with sham coilTMS with sham coil is a placebo | Device | Sham Stimulation |
Primary outcome
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
Time frame: up to 1 months
The Yale-Brown Obsessive Compulsive Scale is a test to rate the severity of obsessive-compulsive disorder symptoms, which measures obsessions separately from compulsions. The scale includes 10 items, the first 5 items are evaluated obsessions, the rest are assessments compulsions. Each item 0-4 points, a total of 40 points. The lower the score, the better the outcome.
5 secondary outcomes
Stop-Signal Task
Time frame: pre-treatment; 1 day post-treatment
Task Switch
Time frame: pre-treatment; 1 day post-treatment
Wisconsin CardSorting Test
Time frame: pre-treatment; 1 day post-treatment
Hanoi Tower
Time frame: pre-treatment; 1 day post-treatment
Symptom improvement assessed by the Padua Inventory-Washington State University Revision
Time frame: up to 1 months
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 4 Jan 2022.
Related trials for Obsessive-Compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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 transcranial magnetic stimulation with real coil in people with Obsessive-Compulsive Disorder 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 4 inclusion and 1 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 4 Jan 2022. 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?
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (time frame: up to 1 months). 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 4 Jan 2022.