Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MR/T023007/1 | Other Grant/Funding Number | UKRI MRC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study explores the potential of transcranial ultrasound stimulation (TUS) as an innovative therapeutic approach for individuals with obsessive-compulsive disorder (OCD). By targeting specific brain regions associated with compulsive behaviors and anxiety, the researchers aim to assess the safety and efficacy of TUS in reducing symptoms and enhancing cognitive flexibility.
Obsessive Compulsive Disorder (OCD) is a common and highly debilitating disorder with the manifestation of obsessions/compulsions and is associated with a significant impairment in social functioning and quality of life. Estimates show that the effects of OCD create an economic burden of £5 billion/year in the UK alone (Kochar et al. 2023). Novel interventions with greater efficacy in addressing the symptoms of OCD in patients, aiming to surpass the current standards of effectiveness and comprehensiveness in treatment outcomes are needed. Low-intensity transcranial focused ultrasound stimulation (TUS) is a promising emerging non-invasive brain stimulation technique which can neuromodulate any brain region with high spatial resolution.
The neural underpinning of OCD is thought to involve many prefrontal regions including the anterior cingulate cortex (ACC) but also deeper brain regions like the striatum (habit formation: Ahmari et al. 2017, Denys et al. 2013), the thalamus (Subirà et al. 2016) and the amygdala (overactivity: Fullana et al. 2020, Milad et al. 2013). TUS can focally induce changes in neuronal activity in both cortical and subcortical brain regions with incredibly high spatial resolution (Darmani et al. 2022). The current study will focus on targeting multiple regions playing a significant role in regulating various cognitive and repeated actions in OCD. We will assess safety and efficiency of TUS to different parts of the brain in alleviating OCD symptoms.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUS sham | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
|
| TUS Active | Other | double-blind, sham-controlled, crossover study in N=30 individuals with OCD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low intensity transcranial focused ultrasound stimulation (TUS) | Device | Low-intensity transcranial focused ultrasound (TUS) provides an energy source with millimeter resolution that can be focused anywhere in the brain safely and effectively for non-invasive and transient neuromodulation. TUS is an important advance and of great significance for brain-mapping efforts, diagnostics, and therapies in neuroscience and particularly promising for addiction therapy as it provides unprecedented non-surgical access to the brain regardless of depth. Low intensities of focused ultrasound (TUS) are used so that tissue damage does not occur, but neural activity can be modulated by mechanical effects. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | number of adverse events | Immediately after TUS session; one day and one week after TUS. Same for sham, to compare the TUS active and sham. |
| Measure | Description | Time Frame |
|---|---|---|
| reduction in OCD symptoms | numerical OCD symptoms rating scale | immediately prior to TUS sessions, within 1 hour post TUS and every day that follow TUS for 7 days |
Not provided
Inclusion Criteria will be:
Exclusion Criteria will be:
The participant may not enter the trial if ANY of the following apply.
History:
Current:
Last 24 hours:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elsa F Fouragnan, Ph.D. | University of Plymouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health | Plymouth | Devon | PL4 8AA | United Kingdom |
Not provided
| Label | URL |
|---|---|
| safety report for TUS use from expert consortium | View source |
Not provided
Anonymous behavioral data upon publication
data will be available after analysis of primary and secondary outcomes are completed
anyone with access to the link to the data (OSF)
Not provided
Within subject, randomized, double-blind, sham-controlled trial
Not provided
Not provided
Not provided
|
|
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided