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Obsessive Compulsive Disorder (OCD)NCT04432246

Electroencephalography Predictors of Repetitive Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder

A study testing Continuous theta burst stimulation (cTBS) in people with Obsessive Compulsive Disorder (OCD), run by Shanghai Mental Health Center at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Obsessive Compulsive Disorder (OCD)
What is being tested?
Continuous theta burst stimulation (cTBS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
11 Jun 2020to 30 Aug 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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • age>18 years old;
  • DSM-5 criteria for OCD;
  • Y-BOCS total score > or = 16 ->or＝9 yrs education

Who cannot join

  • any additional current psychiatric comorbidity, except for obsessive-compulsive personality disorder serious suicide risk;
  • the inability to receive rTMS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery;
  • any major medical disease;
  • pregnancy or nursing of an infant;
  • participation in current clinical study;
  • current use of any investigational drug;
  • TMS/DBS treatment at any point in their lifetime;
  • history of long-time use of benzodiazepines

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: Electroencephalography (EEG) Predictors of Repetitive Transcranial Magnetic Stimulation (rTMS) in Obsessive-Compulsive Disorder (OCD): A Preliminary Study

This study used electroencephalogram (EEG) to predict the efficacy of repetitive transcranial magnetic stimulation (rTMS) in patients with obsessive-compulsive disorder.

Read the detailed description

Repetitive Transcranial Magnetic Stimulation (rTMS), as a relatively mature non-invasive neuromodulation technology, has been recommended for the treatment of patients with refractory OCD in multinational guidelines. However, due to the treatment setting and the patient's feature, nearly half of the patients have no significant changes after rTMS treatment.

In order to better predict the outcome of rTMS and improve the treatment efficiency, this project intends to look for markers that have a predictive effect at baseline or early treatment. Electroencephalogram (EEG) is a cheap and fast method that usually occurs before the symptoms change, thus it is possible to determine whether the patient has responded to the intervention.

In this project, the supplementary motor area (SMA) is selected as the stimulation target. The individual head magnetic resonance image positioning and navigation and rTMS compatible real-time EEG acquisition technology are used to monitor the resting state of EEG and rTMS single pulse stimulation and changes in neural networks before and after treatment. This is a preliminary exploration looking for effective predictive indicators of efficacy in EEG and the relationship between EEG and symptoms changes. In order to lay the foundation for further research and guide clinical treatment.

Being tested
Continuous theta burst stimulation (cTBS)
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.

  • Continuous theta burst stimulation (cTBS)Device

    50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses

Study groups in NCT04432246
Study groupRoleWhat they receive
bilateral SMAExperimentalContinuous theta burst stimulation (cTBS) stimulation will be applied over the bilateral SMA once a day, 5 days/week, for 4 weeks.
Receives: Device: Continuous theta burst stimulation (cTBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe.The responder on Y-BOCS is defined as a Y-BOCS decrease at least 35% from the baseline at post-treatment.

    Measured: Up to 6 months

  2. EEG biomarkers as predictors of response to rTMS

    TMS-EEG and resting state EEG will be performed to investigate predictors of response to rTMS in OCD patients. The α, β and δ band power in resting state in each brain area of OCD patients will be recorded and analyzed. Also, in TMS treatment, event related potentials (ERPs) including motor evoked potentials (MEPs) amplitude, I waves, α band power and β band power will be analyzed.

    Measured: baseline

Secondary outcomes (6)

  1. Change in The Beck Depression Inventory (BDI)

    It consists of 21 items and uses a 0 to 3 severity scale. Total scores range from 0 to 63, with higher scores indicating more severe depression symptoms.

    Measured: Up to 6 months

  2. Change in The Beck Anxiety Inventory (BAI)

    It is an inventory of anxiety symptoms with 18 items that are rated on a 5-point Likert scale(0 to 4). Total scores range from 0 to 72, with higher scores indicating more severe anxiety symptoms.

    Measured: Up to 6 months

  3. Change in The Perceived Stress Scale(PSS)

    The Perceived Stress Scale (PSS) has 10 items to assess stress status within four weeks. Items are classified into five levels, from 0 (never) to 4 (very often). Total scores range from 0 to 40. The higher the total score, the stronger the level of stress the patient feels.

    Measured: Up to 6 months

  4. Change in Pittsburgh sleep quality index(PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).

    Measured: Up to 6 months

  5. Change in Obsessive Compulsive Inventory-Revised(OCI-R)

    It is an inventory of OCD symptoms with 18 items that are rated on a 5-point Likert scale. Total scores range from 0 to 72, with higher scores indicating more severe OCD symptoms.

    Measured: Up to 6 months

  6. Change in Side-effect questionnaire

    It consists of 10-item and uses 0 to 3 severity scale to rate the intensity of side effects. Total scores range from 0 to 30, with higher scores indicating more severe side-effect. It also assesses the relation between side-effect and the effects of rTMS using 0 to 4 scale. Total scores range from 0 to 40, with higher score indicating the greater relation.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start11 Jun 2020
  3. Primary completion28 Jul 2022
  4. Study completion30 Aug 2022

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432246
Sponsor's protocol ID
SMHC-OCD-007
Status last verified
Sep 2022
First submitted
11 Jun 2020
Last updated
9 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Continuous theta burst stimulation (cTBS) in people with Obsessive Compulsive Disorder (OCD), run by Shanghai Mental Health Center 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 3 inclusion and 8 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 9 Sep 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. 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 symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: Up to 6 months). 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 NCT04432246.

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 9 Sep 2022.

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