Health TrialsbyHealthPanel

Effects of Excitatory and Inhibitory LIFUS of GPi in Parkinsonian Patients Without DBS

ConditionParkinson Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Health Network, Toronto

About this trial

Low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation (NIBS) technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. This study will look at the effects of two different LIFUS stimulations on task performance in patients with Parkinson's disease. The effects of real stimulation will also be compared to sham stimulation. The evaluations will include behavioral tasks on the computer, the Unified Parkinson's Disease Rating Scale (UPDRS) motor scoring, and finger accelerometry recordings. These will be done before the LIFUS simulations and repeated after. This is to evaluate the different mechanisms and efficacy of these stimulations on deep brain areas.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-90 years of age

Confirmed diagnosis of Parkinson's disease

Stable dopaminergic medication dose for a minimum of 4 weeks

Disqualifiers

History of stroke or seizure

Comorbid dementia

Scored below 22 on the Montreal Cognitive Assessment (MoCA)

Has intracranial implant(s) or device(s)

Trial design

Design model

Single group

Treatments tested in this trial

  • LIFUS: Active 5 Hz Theta Burst

    Device

    LIFUS 5 Hz theta burst bilaterally on the GPi

  • LIFUS: Active 10 Hz

    Device

    LIFUS 10 Hz bilaterally on the GPi

  • LIFUS: Sham

    Device

    Sham: LIFUS theta burst to occipital lobe

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Low Intensity Focused UltrasoundExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Stop-Signal Task

Time frame
Visits 2-4: before stimulation, 20 minutes post round 1 of stimulation, and 25 minutes post round 2 of stimulation

Secondary outcomes

1

Unified Parkinsons Disease Rating Scale (UPDRS)

Part III - Motor Assessment

Time frame
Visits 2-4: At the beginning of the visit, and at the end of the visit after all stimulation. Visits 2-4 will take place over at least 3 weeks as each visit is at least 1 week apart.
2

Rest Tremor

Resting tremor will be measured by an accelerometer

Time frame
Visits 2-4: resting tremor will be recorded by an accelerometer periodically during each visit. This will be over at least 3 weeks, since each visit is at least 1 week apart.
3

Postural Tremor

Postural tremor will be measured as arms are outstretched using an accelerometer

Time frame
Visit 2 - 4. At each visit, it will be recorded twice. Once before the stimulation and another after. This will take place over at least 3 weeks, since each visit is at least 1 week apart.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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