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NCT Number: NCT07480408

Neural Mechanisms of the Sensorymotor Circuit in Sensory Phenomena in OCD

The goal of this clinical study is to investigate the neural mechanisms of abnormal sensory phenomena in patients with Obsessive-Compulsive Disorder and to evaluate whether modulation of the insula-supplementary motor area circuit can improve these symptoms. The study will include adult patients with OCD (with or without sensory phenomena) and healthy volunteers.

The main questions it aims to answer are:

* Do patients with OCD show abnormal activity in the insula-SMA circuit compared with healthy controls? * Is this abnormality associated with the presence and severity of abnormal sensory phenomena? * Can low-frequency rTMS targeting the Supplementary Motor Area improve sensory phenomena and obsessive-compulsive symptoms? Researchers will compare an on-line rTMS group (viewing body-focused videos during stimulation) with an off-line rTMS group (resting during stimulation) to evaluate whether task engagement enhances treatment effects.

Participants will:

* Complete clinical assessments and behavioral tasks. * Undergo EEG and fMRI assessments. * Receive low-frequency rTMS targeting the Supplementary Motor Area. * Repeat assessments after the intervention.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Phase 1:

This part adopts a cross-sectional design. A total of 30 patients with Obsessive-Compulsive Disorder with sensory phenomena, 30 OCD patients without sensory phenomena, and 30 healthy controls will be recruited. Clinical assessments will be conducted, including evaluation of the severity of sensory phenomena, as well as obsessive-compulsive, depressive, and anxiety symptoms. Resting-state functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data will be collected. In addition, during a body-focused video task designed to activate the insula-SMA circuit, task-based fMRI-EEG data will be simultaneously acquired.

Phase 2:

This part adopts a randomized parallel controlled design. Based on the 30 OCD patients with sensory phenomena included in Phase 1, an additional 30 patients will be recruited, resulting in a total of 60 OCD patients with sensory phenomena. After completing baseline clinical scale assessments, behavioral tasks, fMRI, and EEG data collection, participants will be randomly assigned to an on-line group or an off-line group. Both groups will receive low-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the Supplementary Motor Area for six consecutive days, with five sessions per day. In the on-line group, participants will watch body-focused sensory videos during each stimulation session, whereas the off-line group will remain at rest during stimulation. After completion of the intervention, clinical scale assessments, behavioral tasks, and fMRI and EEG data collection will be repeated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

OCD with abnormal sensory phenomena

  • Meet the diagnostic criteria for Obsessive-Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
  • Aged 18-55 years.
  • Score ≥16 on the Yale-Brown Obsessive Compulsive Scale, indicating moderate to severe symptoms.
  • Score >6 on the Sensory Phenomena Scale (SPS), indicating moderate to severe sensory phenomena.
  • Right-handed.
  • Either medication-free or on stable medication for at least 8 weeks.

OCD without abnormal sensory phenomena

  • Meet the diagnostic criteria for Obsessive-Compulsive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
  • Aged 18-55 years.
  • Score ≥16 on the Yale-Brown Obsessive Compulsive Scale.
  • Score ≤6 on the Sensory Phenomena Scale (SPS).
  • Right-handed.
  • Either medication-free or on stable medication for at least 8 weeks.

Exclusion criteria

  • Meeting diagnostic criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition for psychiatric disorders other than OCD or obsessive-compulsive personality disorder.
  • OCD symptoms so severe that required assessments cannot be completed.
  • Presence of severe suicidal ideation or high suicide risk.
  • Pregnant women or women planning pregnancy in the near future.
  • History of epilepsy or any medical condition that may induce seizures or intracranial hypertension.
  • Contraindications to MRI, such as metallic implants.
  • Clinically significant medical illnesses or abnormal laboratory findings.
  • Inability to complete study procedures due to severe symptoms, low cognitive functioning, or poor cooperation.

Healthy Controls Inclusion criteria

  • No current or past psychiatric disorders meeting diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
  • Aged 18-55 years.
  • Right-handed. Exclusion criteria
  • Pregnant women or women planning pregnancy in the near future. 2. History of epilepsy or any medical condition that may induce seizures or intracranial hypertension.
  • Presence of severe suicidal ideation or high suicide risk. 4. Contraindications to MRI, such as metallic implants. 5. Clinically significant medical illnesses or abnormal laboratory findings. 6. Inability to complete study procedures due to severe symptoms, low cognitive functioning, or poor cooperation.

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

Repetitive transcranial magnetic stimulation (rTMS) will be delivered at 1 Hz with a total of 1,200 pulses per session, administered five times per day for six consecutive days. Target localization will be based on each participant's T1-weighted structural MRI, using a neuronavigation system to establish an individualized head model and identify the Supplementary Motor Area. The stimulation intensity will be set at 110% of the individual resting motor threshold (RMT).

Primary outcomes

  1. Change in Yale-Brown Obsessive Compulsive Scale(Y-BOCS) score

    Time frame: Up to 6 days

    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.

Secondary outcomes

  1. Change in Sensory Phenomena Scale (SPS) score

    Time frame: Up to 6 days

    A semi-structured scale used to assess the presence and severity of sensory phenomena occurring before or during repetitive behaviors. It consists of two parts: a symptom checklist and a severity rating.

  2. Change in Beck Depression Inventory(BDI) score

    Time frame: Up to 6 days

    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.

  3. Change in Beck Anxiety Inventory (BAI) score

    Time frame: Up to 6 days

    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.

  4. Change in Perceived Stress Scale(PSS) score

    Time frame: Up to 6 days

    It is a 10-item, 5-point Likert scale(0 to 4) to measure the degree to which situations in one's life are appraised as stressful.The total score ranges from 0 to 40, with lower total scores representing a better outcome.

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

    Time frame: Up to 6 days

    It is a self-report instrument derived from the original 42-item OCI for assessing obsessive-compulsive symptoms. It contains 18 items divided into six subscales, each with three items, assessing six symptom dimensions: washing, obsessing, hoarding, ordering, checking, and neutralizing. Each item is rated on a 5-point scale from 0 to 4, with higher scores indicating more severe symptoms.

  6. Change in Obsessive Beliefs Questionnaire (OBQ) score

    Time frame: Up to 6 days

    This scale consists of 44 items and includes three factors: responsibility/threat estimation, perfectionism/certainty, and importance/control of thoughts.

  7. Change in Intolerance Of Uncertainty Scale (IUS-12) score

    Time frame: Up to 6 days

    This scale consists of 12 items rated on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree." Higher scores indicate lower tolerance of uncertainty. The scale includes two dimensions: inhibitory anxiety and prospective anxiety.

  8. Change in Intolerance Of Not Just Right Experiences Questionnaire Revised, (NJRE-Q-R) score

    Time frame: Up to 6 days

    This scale is used to assess the presence and severity of Not Just Right Experiences in individuals.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayue Cheng, Master

CONTACT

[email protected]

+8602134773503

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Neural Mechanisms of the Insula-Supplementary Motor Area Circuit in Sensory Phenomena in Obsessive-Compulsive Disorder

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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