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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Portugal
Champalimaud Foundation
RECRUITING
Lisbon
Contact Information
Primary
Sofia Marques
sofia.marques@research.fchampalimaud.org
(+351) 210 480 048
Backup
Gonçalo Cotovio, MD, PhD
goncalo.cotovio@neuro.fchampalimaud.org
(+351) 210 480 048
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 32
Treatments
Active_comparator: Arm A
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.
Experimental: Arm B
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.
Related Therapeutic Areas
Sponsors
Leads: Fundacao Champalimaud

This content was sourced from clinicaltrials.gov