Viewing Study NCT06490965



Ignite Creation Date: 2024-07-17 @ 11:29 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06490965
Status: RECRUITING
Last Update Posted: 2024-07-08
First Post: 2024-07-01

Brief Title: Improving Obsessive-compulsive Disorder Treatments From Lesions to Neuromodulation Targets
Sponsor: Fundacao Champalimaud
Organization: Fundacao Champalimaud

Study Overview

Official Title: Improving Obsessive-compulsive Disorder Treatments From Lesions to Neuromodulation Targets
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ON-TARGET
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
Detailed Description: In this study we hypothesize that the cortical region identified from connectivity networks associated with lesional OCD may be a more effective TMS stimulation site than the one currently used in OCD treatment Thus we intend to compare the efficacy of the TMS protocol as approved for OCD between its application at the currently used stimulation site bilateral dorsomedial prefrontal cortex and its application at an adjusted stimulation site according to the more specific cortical areas of dysfunctional circuits associated with lesional OCD namely the bilateral medial orbitofrontal cortex OFC region

The participants in this study will be recruited at the Champalimaud Foundation The physicians on the research team will identify patients who are being treated for OCD in the Neuropsychiatry Unit or who are referred to the unit for this purpose In this study we aim to prospectively recruit 32 individuals according to the eligibility criteria specified in the respective section

We propose to conduct a randomized double-blinded interventional study open only to the technician administering the treatment After agreeing to participate in the study the participant will be invited to attend the first study visit There participants will be assigned a unique identification number to maintain their anonymity in the study Then a qualified team member will ask the participant to complete the sociodemographic and clinical questionnaire to confirm the conditions for TMS and MRI including an appropriate screening tool for the occurrence of seizures andor epilepsy The Mini International Neuropsychiatric Interview MINI and he Structured Clinical Interview for Diagnostic and statistical manual of mental disorders SCID will serve the purpose of verifying the eligibility criteria of the study participant including confirmation of the OCD diagnosis using SCID After confirming their eligibility the participant will be invited to complete the remaining psychometric assessment which will reflect the baseline values of each instrument The following will be assessed YBOCS-II primary outcome BDI-II OCI-R STAI World Health Organization Five Well-Being Index WHO-5 and YMRS secondary outcomes and Edinburgh Handedness Inventory EHI

In this study to ensure that the TMS target site used is precisely located we will use neuronavigation in each TMS session performed Thus in the next step of the first visit the participant will be invited to undergo an MRI scan This procedure cannot be waived as without the MRI scan of each individual the appropriate use of neuronavigation is compromised If the participant cannot or does not want to undergo this procedure they will be excluded from the study The MRI protocol will include the collection of structural and functional neuroimaging data The duration of this neuroimaging exam will be approximately 20-30 minutes

After completing this step the participant will be randomized to one of the two study arms Please see details of each study arm in the respective section The first visit of the TMS treatment cycle will be scheduled later During this first visit of the TMS treatment cycle the motor hotspot and the motor excitability threshold will be determined which will be subsequently used to define the appropriate treatment intensity for each individual Finally the stimulation site will be determined using the neuronavigation system utilizing each individuals MRI scan It is emphasized that the stimulation site will be mandatory determined at all TMS treatment visits The TMS protocol will then commence characterized by 20 Hz frequency irrespective of study arm At the beginning of each TMS treatment cycle visit the presence of potential side effects since the last TMS session will be screened Every 5 TMS treatment cycle visits 1st 6th 11th 16th 21st and 26th visits the following psychometric scales will be repeated at the beginning of each visit BDI-II WHO-5 OCI-R and YMRS secondary outcomes Every 5 TMS treatment cycle visits 1st 6th 11th 16th 21st and 26th visits the motor hotspot and the motor excitability threshold will be redefined and consequently the treatment stimulation intensity will be adjusted At the end of each TMS treatment cycle visit the next visit will be scheduled to occur on a daily basis on business days for a total of 30 visits After the end of the TMS treatment cycle the last study visit will be scheduled primary endpoint end-of-study visit which should preferably occur between 2-3 weeks after the 30th TMS treatment cycle visit During this visit the YBOCS-II primary outcome will be applied Participants will also be invited to undergo a new MRI scan with the same characteristics as identified above

Clinical efficacy will be assessed by changes in the severity of OCD symptoms compared to baseline evaluated using YBOCS-II primary outcome after 30 daily sessions of TMS comparing the two study arms

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
31379 OTHER_GRANT None None