Recruiting

Deep Brain Stimulation

Sponsor:

University of Toronto

Code:

NCT04093544

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation

Study Details

Brief summary:

Exploring directional lead

Conditions

Parkinson Disease

Study ID

NCT04093544

Start date

May 15, 2018

Status verified date

Sep, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

May 15, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

1. Patients with a diagnosis of Parkinson's disease (PD) according to the British Parkinson's Disease Society Brain Bank criteria, who fulfilled the inclusion and exclusion criteria proposed by the core assessment programme for surgical interventional therapies in PD panel
2. Male and female patients with idiopathic PD, who have symptoms responsive to L- dopa medications, but who have significant impairment related to PD that is no longer well controlled with pharmacotherapy (i.e., refractory to optimized medical therapy)
3. Patients considered as subthalamic nucleus deep brain stimulation (STN-DBS) candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
4. Patients aged 18 to 80 years.
5. Quality of life and social functioning influenced by levodopa-responsive symptoms 6) No major comorbidities

Exclusion criteria will include patients with other significant neurologic or psychiatric illnesses or cognitive deficit.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Stimulation

Participants will receive stimulation using the best contact combination in ring mode.

experimental: Directional Stimulation

Participants will receive stimulation using the best segmented (steered) contacts.

Interventions

Deep brain stimulation

Steered stimulation using directional leads

Primary outcome measure

  • Number/incidence of adverse events [ Time Frame: Throughout the study, averaging 6 months ]

Central Contacts and Locations

Locations

Movement disorders Centre, Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Alfonso Fasano, MD, PhD

+1 416 603 5800alfonso.fasano@uhn.ca

More Information

Sponsor

University of Toronto

Last update posted

Sep 18, 2019

Last verified

Sep, 2019

Keywords

  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2019-09-18.