Improving Obsessive-compulsive Disorder Treatments: from Lesions to Neuromodulation Targets

NCT06490965 | Recruiting

• 2 other identifiers: ON-TARGET31379
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

While in most cases of obsessive-compulsive disorder (OCD) a cause cannot be identified, this syndrome may develop as a consequence of focal brain lesions. Neuropsychiatric disorders secondary to brain insults are open windows to understand their underlying neurobiology. Different neuroimaging analysis methods, including pooled lesion topography and lesion network mapping, can be used to study lesional neuropsychiatric syndromes, including OCD. If successful, these strategies can also reveal new neuromodulation treatment targets, including for transcranial magnetic stimulation (TMS). Indeed, TMS targets to treat depression evolved from evidence extracted from lesional studies that were then refined and validated. For OCD treatment with TMS, already approved by the FDA and European Commission, targets were defined using a distinct approach, not involving causal brain lesions, which may contribute to lower than desirable remission rates. Lesional OCD is characterized by specific dysfunctional brain circuits. These circuits may be effectively targeted by TMS, which may optimize treatment of OCD. To address these hypotheses, we will test the therapeutic benefits of optimizing brain targets for the currently used TMS treatment of OCD, using information from the lesional-OCD brain network namely refining the target in the medial orbitofrontal cortex, bilaterally. Specifically, we will conduct a randomized clinical interventional study, using TMS to treat patients with OCD with inadequate response to other treatments, comparing, within the approved protocol for OCD treatment, the most frequently used stimulation site with a new target, adjusted according to the connectivity of lesions associated with the occurrence of OCD. If successful, our results may have immediate clinical implications in OCD treatment, as it will contribute to refine current therapeutic TMS strategies for OCD and defining new clinical research strategies in this domain.

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive Compulsive Scale - II (YBOCS-II)

  Assessment instrument for the severity of OCD symptoms; scores can range from 0-50; higher scores mean worse outcome.

  Before and after TMS treatment cycle. The latter will be considered the primary endpoint (end-of-study visit) and will occur preferably between 2-3 weeks after last TMS session.

Secondary Outcomes (5)

• State Trait Anxiety Inventory (STAI)

  Before and after TMS treatment cycle. The latter will be considered the primary endpoint (end-of-study visit) and will occur preferably between 2-3 weeks after last TMS session.

• Beck Depression Inventory II (BDI-II)

  Before TMS treatment cycle. Every 5 TMS treatment cycle visits (1st, 6th, 11th, 16th, 21st, and 26th visits). After TMS treatment cycle, i.e., 2-3 weeks after last TMS session.

• Obsessive-Compulsive Inventory - Revised (OCI-R)

  Before TMS treatment cycle. Every 5 TMS treatment cycle visits (1st, 6th, 11th, 16th, 21st, and 26th visits). After TMS treatment cycle, i.e., 2-3 weeks after last TMS session.

• Young Mania Rating Scale (YMRS)

  Before TMS treatment cycle. Every 5 TMS treatment cycle visits (1st, 6th, 11th, 16th, 21st, and 26th visits). After TMS treatment cycle, i.e., 2-3 weeks after last TMS session.

• World Health Organization Five Well-Being Index (WHO-5)

  Before TMS treatment cycle. Every 5 TMS treatment cycle visits (1st, 6th, 11th, 16th, 21st, and 26th visits). After TMS treatment cycle, i.e., 2-3 weeks after last TMS session.

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Standard of care rTMS protocol, i.e., daily frequency of repetitive excitatory TMS at 20 Hz of the medial prefrontal cortex - approximate duration of each session between 40-60 minutes.

Other: Repetitive Transcranial Magnetic Stimulation; Other: Neuronavigation; Other: Magnetic Resonance Imaging

Arm B

EXPERIMENTAL

Standard of care rTMS protocol, i.e., daily frequency of repetitive excitatory TMS at 20 Hz with adjustment of the stimulation site to primarily target the bilateral medial orbitofrontal cortex.

Other: Repetitive Transcranial Magnetic Stimulation; Other: Neuronavigation; Other: Magnetic Resonance Imaging

Interventions

Repetitive Transcranial Magnetic Stimulation OTHER

Transcranial Magnetic Stimulation (TMS) involves generating a magnetic field with specific spatial and temporal properties, allowing the induction of electric current in conductive material near this field. The electro-physiological principle of TMS is based on placing a coil over the skull that will induce a magnetic field generating action potentials in neuronal tissue in response to each TMS pulse. The repetitive application of TMS pulses (rTMS) allows for the modulation of neuronal excitability for a period after rTMS, ranging from inhibition, in the case of low frequencies (\~1 Hz), or facilitation if high frequencies (equal to or greater than 5 Hz) are used.

Also known as: rTMS, TMS, Non Invasive Brain Stimulation

Arm A; Arm B

Neuronavigation OTHER

Neuronavigation is a non-invasive method that allows the creation of computerized three-dimensional models of brain structures based on neuroimaging exams of each individual (e.g., cranial magnetic resonance imaging). As such, this method has been used for various purposes, such as assisting in neurosurgery or mapping functional regions of the brain, but also in the context of TMS (Transcranial Magnetic Stimulation). In this latter area, its use as support for TMS has been employed for therapeutic, diagnostic, and research purposes. The neuronavigation system consists of several components, namely a locating camera, locators for the TMS coil, an adjustable headband with locators, a calibration system for these elements, and the neuronavigation software, which is installed on a supporting computer.

Arm A; Arm B

Magnetic Resonance Imaging OTHER

Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that generates detailed images of the internal structures of the body using a strong magnetic field and radio waves. It provides high-resolution images of soft tissues, such as organs, muscles, and the brain, helping doctors diagnose and monitor various conditions, including injuries, tumors, and neurological disorders. MRI is particularly useful because it does not involve ionizing radiation, making it safer for patients than other imaging methods like X-rays or CT scans.

Also known as: MRI

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years;
• Established diagnosis of Obsessive-Compulsive Disorder according to Diagnostic and statistical manual of mental disorders 5 (DSM5) criteria;
• Capacity to give consent;
• Fluent in Portuguese and/or English;
• If potential for pregnancy, agrees to use an effective method of contraception throughout the study period.

You may not qualify if:

• Obsessive-compulsive symptoms severity assessed at baseline visit with the instrument Yale-Brown Obsessive Compulsive Scale - II (YBOCS-II) ≤ 24;
• Presence of uncontrolled active medical illness;
• Known structural lesion of the central nervous system;
• Electric or metallic implants in the body not compatible with electromagnetic radiation;
• Electric or metallic brain implants;
• Cardiac implants;
• Epilepsy;
• Pregnant, breastfeeding, or planning pregnancy women;
• Alcohol or substance abuse and/or dependence;
• Major Neurocognitive Disorder;
• Developmental disorders with low intelligence quotient or any other form of cognitive deficit;
• Active neurological disease;
• Individuals presenting with any psychotic or mood disorder requiring hospitalization at the time of eligibility criteria assessment;
• Contraindication for performing MRI;
• Individuals who have already been treated for OCD with TMS;

Sponsors & Collaborators

• Fundacao Champalimaud: lead

Study Sites (1)

Champalimaud Foundation

Lisbon, 1400-038, Portugal

RECRUITING

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MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation; Neuronavigation; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Surgery, Computer-Assisted; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Gonçalo Cotovio, MD, PhD

  Champalimaud Foundation

  PRINCIPAL INVESTIGATOR

• Albino J. Oliveira-Maia, MD, MPH, PhD

  Champalimaud Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Marques

CONTACT

(+351) 210 480 048; sofia.marques@research.fchampalimaud.org

Gonçalo Cotovio, MD, PhD

CONTACT

(+351) 210 480 048; goncalo.cotovio@neuro.fchampalimaud.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 8, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)