Obsessive-Compulsive DisorderNCT05221632
Accelerated Continue Theta-burst Stimulation (acTBS)Treatment for Obsessive Compulsive Disease
A study testing Accelerated transcranial magnetic stimulation with real coil and Transcranial magnetic stimulation with real coil in people with Obsessive-Compulsive Disorder and Accelerated Continue Theta-burst Stimulation, run by Anhui Medical University at 1 site in China.
Trial summary
The therapeutic effects of high-dose accelerated continue theta-burst stimulation (acTBS) and 1-Hz repetitive transcranial magnetic stimulation (rTMS) on obsessive-compulsive disorder (OCD) and its neural mechanism were investigated by functional MRI. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Accelerated Continue Theta-burst Stimulation, Transcranial Magnetic Stimulation
- What is being tested?
- Accelerated transcranial magnetic stimulation with real coil and 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of obsessive-compulsive disorder
- 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.
China1 site, 1 recruiting
- Recruiting
Anhui Medical University
Hefei, Anhui, 230032
Chunyan Zhu, professor, +86-0551-62923704, ayswallow@126.com
About this study
Official title: Accelerated cTBS and 1HZ-rTMS in the Treatment of Obsessive-compulsive Disorder With Individualized Stimulation Target
The therapeutic effects of high-dose accelerated continue theta-burst stimulation (acTBS) and 1-Hz repetitive transcranial magnetic stimulation (rTMS) on obsessive-compulsive disorder (OCD) and its neural mechanism were investigated by functional MRI.
Read the detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to 1-Hz rTMS group，acTBS group and sham group. Patients ware allocated by random number. The decision to enroll a patient was always made prior to randomization. The 1-Hz rTMS group received one round of stimulation every day for 30 minutes with a total stimulation of 1800 pulses for 5 consecutive days. Patients in the acTBS group received 10 two-minute rounds of stimulation each day, spaced 50 minutes apart, with a total of 18,000 pulses for five days.
Before the TMS treatment, Y-BOCS, Obsessions Symptom Scale revised (OCI-R), Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA-14) were obtained by a trained investigator to assess baseline severity 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。
After the last treatment, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), OCI-R, 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 5 days.The patients had also receiving a battery measure of neuropsychological tests and magnetic resonance imaging scan in multimodalities.
Participants were interviewed for two and four weeks after their last treatment to obtain a Y-BOCS score, and they were asked to focus their answers on the past week.
- Conditions
- Obsessive-Compulsive Disorder, Accelerated Continue Theta-burst Stimulation, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging
- Being tested
- Accelerated transcranial magnetic stimulation with real coil, 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.
Accelerated transcranial magnetic stimulation with real coilDevice
The stimulation mode of TMS is accelerated continue theta-burst stimulation.
Transcranial magnetic stimulation with real coilDevice
The stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation .
Transcranial magnetic stimulation with sham coilDevice
The stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| accelerated continue theta-burst stimulation | Experimental | Fifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last cTBS session. Receives: Device: Accelerated transcranial magnetic stimulation with real coil |
| 1-HZ repetition transcranial magnetic stimulation 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 80% 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 |
| accelerated continue theta-burst stimulation (sham) | Sham comparator | Fifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last rTMS session. No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first cTBS session and after the last cTBS 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: pre-treatment; 1 day post-treatment; Change from baseline score at 1 month
Secondary outcomes (5)
Obsessive Compulsive Inventory-Revised (OCI-R)
a simplified version of the OCI for self-assessment of Obsessive symptoms, Revised to include only 18 items from 42 items in the original Obsessive Compulsive Questionnaire. Divided into six obsessional subscales, respectively washing (5, 11, 17), obsessional thinking (6, 12, 18), storage (1, 7, 13), sorting (3, 9, 15), check (2, 8, 14), mixed (4, 10, 16), can be very good to distinguish the characteristics of different obsessional symptoms. Each item was assessed on a five-point scale of 0 to 4, with 0 being "not at all" and 5 being "extremely painful," and participants were asked to tick a number that best described the extent of their pain or distress on a scale of 0 to 72, with higher scores indicating more severe obsessive-compulsive symptoms. The questionnaire is simple and easy to understand. It can objectively evaluate individual obsessive-compulsive symptoms from six dimensions, with high reliability (0.82) and validity (0.81).
Measured: pre-treatment; 1 day post-treatment
Hamilton Depression Scale（HAMD）
Hamilton Depression Scale（HAMD）: An assessment of depressive mood status with 17 questions on a Scale of 0 to 4.
Measured: pre-treatment; 1 day post-treatment
Hamilton Anxiety Scale（HAMA）
Hamilton Anxiety Scale（HAMA）：a scale of 14 questions on a scale of 0 to 4 on a 5 scale.
Measured: pre-treatment; 1 day post-treatment
Stroop word test
To measure the conflict suppression ability of the subjects, consisting of three groups of cards, namely dot, word and color word. The subjects were asked to read the color as quickly and accurately as possible, and record the response time and accuracy. Behavioral indicators :(Stroop interference effects, SIE)= reaction time of color word - reaction time of word.
Measured: pre-treatment; 1 day post-treatment
Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.
Evaluate the executive function of the subjects, including attention, memory, thinking flexibility, reasoning, conversion and other broad executive function components, including A and B. TMT is simple and involves less cognitive involvement. TMT-B involves response inhibition and attentional switching. The task required the subjects to complete the connection according to certain rules and record the reaction time. Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.
Measured: pre-treatment; 1 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 posted3 Feb 2022
- Study start1 Mar 2021
- Primary completion6 Jan 2022
- Study completion1 Jul 2023 (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 Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Anhui Medical 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT05221632
- Sponsor's protocol ID
- precise high-dose OCD
- Status last verified
- Apr 2023
- First submitted
- 3 Jan 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang J, Wan K, Liu Y, Tang Y, Tang W, Liu J, Ma J, Xue C, Chen L, Qian H, Liu D, Shen X, Fan R, Wang Y, Wang K, Ji G, Zhu C. A Controlled Clinical Study of Accelerated High-Dose Theta Burst Stimulation in Patients with Obsessive-Compulsive Disorder. Neural Plast. 2023 Dec 7;2023:2741287. doi: 10.1155/2023/2741287. eCollection 2023.
PubMed 38099081
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated cTBS and 1HZ-rTMS in the Treatment of Obsessive-compulsive Disorder With Individualized Stimulation Target
- ClinicalTrials.gov ID
- NCT05221632
- Acronym / sponsor ID
- precise high-dose OCD
- Conditions
- Obsessive-Compulsive Disorder, Accelerated Continue Theta-burst Stimulation, Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 3 Feb 2022 (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 therapeutic effects of high-dose accelerated continue theta-burst stimulation (acTBS) and 1-Hz repetitive transcranial magnetic stimulation (rTMS) on obsessive-compulsive disorder (OCD) and its neural mechanism were investigated by functional MRI.
Detailed description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to 1-Hz rTMS group，acTBS group and sham group. Patients ware allocated by random number. The decision to enroll a patient was always made prior to randomization. The 1-Hz rTMS group received one round of stimulation every day for 30 minutes with a total stimulation of 1800 pulses for 5 consecutive days. Patients in the acTBS group received 10 two-minute rounds of stimulation each day, spaced 50 minutes apart, with a total of 18,000 pulses for five days.
Before the TMS treatment, Y-BOCS, Obsessions Symptom Scale revised (OCI-R), Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA-14) were obtained by a trained investigator to assess baseline severity 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。
After the last treatment, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), OCI-R, 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 5 days.The patients had also receiving a battery measure of neuropsychological tests and magnetic resonance imaging scan in multimodalities.
Participants were interviewed for two and four weeks after their last treatment to obtain a Y-BOCS score, and they were asked to focus their answers on the past week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| accelerated continue theta-burst stimulation | Experimental | Device: Accelerated transcranial magnetic stimulation with real coilFifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last cTBS session. |
| 1-HZ repetition transcranial magnetic stimulation 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 80% of the rest motor threshold (RMT) . MRI dataset should be acquired before the first rTMS session and after the last rTMS session. |
| accelerated continue theta-burst stimulation (sham) | Sham comparator | Device: Transcranial magnetic stimulation with sham coilFifty intermittent TBS sessions (1800 pulses per session, 50 minute inter-session interval ) were delivered as ten daily sessions over five consecutive days at 80% resting motor threshold (RMT). The MRI data set should be collected before the first cTBS session and after the last rTMS session. No actual magnetic stimulation was applied on the head of the volunteers. MRI dataset should be acquired before the first cTBS session and after the last cTBS session. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of obsessive-compulsive disorder
- Voluntarily participated and cooperated with the experiment.
Key exclusion criteria (6 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.
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 |
|---|---|---|
| Accelerated transcranial magnetic stimulation with real coilThe stimulation mode of TMS is accelerated continue theta-burst stimulation. | Device | accelerated continue theta-burst stimulation |
| Transcranial magnetic stimulation with real coilThe stimulation mode of TMS is 1-Hz repetitive Transcranial magnetic stimulation . | Device | 1-HZ repetition transcranial magnetic stimulation Stimulation |
| Transcranial magnetic stimulation with sham coilThe stimulation mode of TMS is accelerated continue theta-burst stimulation, but without active stimulation. | Device | accelerated continue theta-burst stimulation (sham) |
Primary outcome
Symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale
Time frame: pre-treatment; 1 day post-treatment; Change from baseline score at 1 month
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
Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: pre-treatment; 1 day post-treatment
Hamilton Depression Scale（HAMD）
Time frame: pre-treatment; 1 day post-treatment
Hamilton Anxiety Scale（HAMA）
Time frame: pre-treatment; 1 day post-treatment
Stroop word test
Time frame: pre-treatment; 1 day post-treatment
Behavioral index TMT=TMT-B reaction time - TMT-A reaction time.
Time frame: pre-treatment; 1 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 14 Apr 2023.
- Derived from this study: PubMed 38099081Jiang J, Wan K, Liu Y, Tang Y, Tang W, Liu J, Ma J, Xue C, Chen L, Qian H, Liu D, Shen X, Fan R, Wang Y, Wang K, Ji G, Zhu C. A Controlled Clinical Study of Accelerated High-Dose Theta Burst Stimulation in Patients with Obsessive-Compulsive Disorder. Neural Plast. 2023 Dec 7;2023:2741287. doi: 10.1155/2023/2741287. eCollection 2023.
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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 Accelerated transcranial magnetic stimulation with real coil and Transcranial magnetic stimulation with real coil in people with Obsessive-Compulsive Disorder and Accelerated Continue Theta-burst 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 2 inclusion and 6 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 14 Apr 2023. 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 Chunyan Zhu, professor (+86-0551-62923704, ayswallow@126.com), or a site near the patient. 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: pre-treatment; 1 day post-treatment; Change from baseline score at 1 month). 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 NCT05221632, 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 14 Apr 2023.