Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232629
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-12-26
Brief Title:
Towards Noninvasive DBS of the Basal Ganglia in Parkinsons Disease Using TUS
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Towards Noninvasive Deep Brain Stimulation of the Basal Ganglia in Parkinsons Disease Using Low-intensity Transcranial Ultrasound Stimulation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
Transcranial Ultrasound Stimulation TUS is an emerging non-invasive brain stimulation technique capable of targeting both superficial and deep brain areas with high spatial resolution down to a few cubic millimeters In this study the investigators aim to use TUS to non-invasively modulate the globus pallidus internus GPi in patients with Parkinsons disease PD and dystonia These patients have previously been implanted with deep brain stimulation DBS leads The investigators plan to simultaneously record local field potentials LFPs from the DBS leads using the Percept PC device Medtronic Inc while the DBS is turned off The studys goal is to investigate the mechanism of action of TUS and its neuromodulatory effects on LFPs recorded from the GPi This will enable us to compare the effects of TUS with those of DBS
Detailed Description:
Study Participants and Visits The investigators will recruit 10-15 PD and dystonia patients who have undergone DBS with lead locations at the GPi These participants will be involved in three study visits
First Visit - MRI Scanning During the first visit participants will undergo a structural MRI scan including T1 and T2 scans at the Toronto Western Hospital using a 30 T Siemens MR-imager These scans are crucial for transcranial ultrasound modeling to accurately localize the targets
Second and Third Visits - Transcranial Ultrasound Stimulation TUS For the second and third visits the investigators will use the Brainsight system and BabelBrain an open source application to neuronavigate the TUS transducer NeuroFUS system This process involves sonication of the GPi with individualized modeling and simulations to account for ultrasound losses due to variations in skull density and morphology The investigators will target the GPi bilaterally where the DBS electrodes are located and record local field potentials LFPs before during and up to one hour post TUS
TUS Protocols Patients will undergo two different TUS protocols across the recording visits assigned in random order and spaced at least one week apart The protocols include
A tbTUS protocol 5Hz Pulse Repetition Frequency PRF previously shown to increase motor cortex excitability for about one hour after sonication and a 10Hz protocol which has been demonstrated to inhibit motor cortical activity for about one hour post sonication
Additionally the investigators will administer two sham-TUS protocols at each visit randomly selected to assess placebo effects and the impact of somatosensory stimulation associated with TUS
The sham protocols are an active sham-TUS for which the investigators will sonicate the occipital cortex Isppa 30 Wcm2 using either 5 or 10 Hz protocols and a passive sham-TUS for which the GPi will be sonicated with either 5 or 10 Hz protocols but at zero power Isppa 0 Wcm2
First Visit - MRI Scanning During the first visit participants will undergo a structural MRI scan including T1 and T2 scans at the Toronto Western Hospital using a 30 T Siemens MR-imager These scans are crucial for transcranial ultrasound modeling to accurately localize the targets
Second and Third Visits - Transcranial Ultrasound Stimulation TUS For the second and third visits the investigators will use the Brainsight system and BabelBrain an open source application to neuronavigate the TUS transducer NeuroFUS system This process involves sonication of the GPi with individualized modeling and simulations to account for ultrasound losses due to variations in skull density and morphology The investigators will target the GPi bilaterally where the DBS electrodes are located and record local field potentials LFPs before during and up to one hour post TUS
TUS Protocols Patients will undergo two different TUS protocols across the recording visits assigned in random order and spaced at least one week apart The protocols include
A tbTUS protocol 5Hz Pulse Repetition Frequency PRF previously shown to increase motor cortex excitability for about one hour after sonication and a 10Hz protocol which has been demonstrated to inhibit motor cortical activity for about one hour post sonication
Additionally the investigators will administer two sham-TUS protocols at each visit randomly selected to assess placebo effects and the impact of somatosensory stimulation associated with TUS
The sham protocols are an active sham-TUS for which the investigators will sonicate the occipital cortex Isppa 30 Wcm2 using either 5 or 10 Hz protocols and a passive sham-TUS for which the GPi will be sonicated with either 5 or 10 Hz protocols but at zero power Isppa 0 Wcm2
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