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TUS for Movement Disorders (TUS-LFP Trial)

Q: How many participants are being recruited for this clinical trial?

<p>Affirmative. As indicated on clinicaltrials.gov, this research endeavour is currently recruiting participants, with first posting on May 18th 2023 and most recent update July 25th 2023. To date the study has been seeking to fill 25 positions at a single site.</p>

Q: Is this trial actively accepting participants?

<p>Affirmative. According to the clinicaltrials.gov portal, this study has been open for enrollment since May 18th 2023 and was most recently updated on July 25th ,2023. This medical trial is seeking 25 patients across a single site.</p>

N/A

Recruiting

Led By Robert Chen, MBBS

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 minutes long recordings during both study visits at 1) baseline (20-30 minutes before sonication), 2) during sonication, 3) 10 minutes after sonication, 4) 30 minutes after sonication, and 5) 45 minutes after sonication

Awards & highlights

TUS-LFP Trial Summary

This trial aims to study how Transcranial Ultrasound Stimulation affects the brain at a high resolution, to better understand its effects and help tune it for future use.

Who is the study for?

This trial is for adults with movement disorders like Essential Tremor, Parkinson's Disease, or Dystonia. They must have a Percept PC DBS system implanted at least one month prior and stable medication doses for four weeks. Excluded are those with other neurological conditions, cognitive decline (MoCA score < 22), certain implants, systemic illness, infection, pregnancy or history of brain lesioning.Check my eligibility

What is being tested?

The study tests Transcranial Ultrasound Stimulation (TUS) effects on brain activity in patients with movement disorders using a DBS system to record local field potentials (LFP). It aims to understand TUS mechanisms and find biomarkers to adjust TUS parameters for future trials.See study design

What are the potential side effects?

As this trial involves non-invasive brain stimulation and monitoring via an already implanted DBS system rather than drug interventions, specific side effects related to the TUS procedure will be monitored but are not extensively known.

TUS-LFP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ online during sonications

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~online during sonications

This trial's timeline: 3 weeks for screening, Varies for treatment, and online during sonications for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

LFP power (Experiment 1)

Stimulation artifact (Experiment 2)

Secondary outcome measures

Adverse effect profile (Experiment 1 and 2)

Finger tapping task (Experiment 1)

UPDRS (Experiment 1)

TUS-LFP Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Low Intensity Transcranial Focused UltrasoundActive Control1 Intervention

NeuroFUS device stimulation with 4 channel transducer Stimulation target = M1/GPi Stimulation parameters = Theta burst protocol and 30 Watts

Group II: Sham Low Intensity Transcranial Focused UltrasoundPlacebo Group1 Intervention

NeuroFUS device stimulation with 4 channel transducer Stimulation target = M1/GPi Stimulation parameters = Theta burst protocol and 0 Watts

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,155 Total Patients Enrolled

2 Trials studying Essential Tremor

100 Patients Enrolled for Essential Tremor

Robert Chen, MBBSPrincipal InvestigatorUniversity Health Network, Toronto

3 Previous Clinical Trials

45 Total Patients Enrolled

Media Library

Active Low Intensity Transcranial Focused Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT05965960 — N/A

Essential Tremor Research Study Groups: Sham Low Intensity Transcranial Focused Ultrasound, Active Low Intensity Transcranial Focused Ultrasound

Essential Tremor Clinical Trial 2023: Active Low Intensity Transcranial Focused Ultrasound Highlights & Side Effects. Trial Name: NCT05965960 — N/A

Active Low Intensity Transcranial Focused Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965960 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being recruited for this clinical trial?

"Affirmative. As indicated on clinicaltrials.gov, this research endeavour is currently recruiting participants, with first posting on May 18th 2023 and most recent update July 25th 2023. To date the study has been seeking to fill 25 positions at a single site."

Answered by AI

Is this trial actively accepting participants?

"Affirmative. According to the clinicaltrials.gov portal, this study has been open for enrollment since May 18th 2023 and was most recently updated on July 25th ,2023. This medical trial is seeking 25 patients across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating LFP Correlates of TUS in Patients With Movement Disorders

Robert Chen 2023. "Investigating LFP Correlates of TUS in Patients With Movement Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05965960.

All > Dystonia > Essential Tremor