Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093544
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Alfonso Fasano, University of Toronto

Brief Summary:
Exploring directional lead

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Deep brain stimulation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads: a Double-blind Cross-over Pilot Study
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Active Comparator: Standard Stimulation
Participants will receive stimulation using the best contact combination in ring mode.
Device: Deep brain stimulation
Steered stimulation using directional leads

Experimental: Directional Stimulation
Participants will receive stimulation using the best segmented (steered) contacts.
Device: Deep brain stimulation
Steered stimulation using directional leads




Primary Outcome Measures :
  1. Number/incidence of adverse events [ Time Frame: Throughout the study, averaging 6 months ]
    Number/incidence of adverse events


Secondary Outcome Measures :
  1. Change from baseline in a measure of health related quality of life and non-motor symptoms of Parkinson's disease using the Parkinson's disease Questionnaire (PDQ-39) [ Time Frame: After 3 months of each intervention ]
    The PDQ-39 assesses individuals experiences across 8 dimensions of daily living. Each dimension is scored from 0 to 100. Lower scores mean better quality of life.

  2. Patients Global Impression of Change (PGIC) [ Time Frame: After 3 months of each intervention ]
    The PGIC evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status relative to baseline. This is a seven point scale, lower values indicating worsening and higher values, improvement.

  3. Change in articulation rate of speech using a Phonetics Software [ Time Frame: After 3 months of each intervention ]
    Sample speeches will be recorded and digitalized at 44,000Hz using a microphone and analyzed with a Phonetics software. Articulation rate is calculated as the number of syllables produced/total time without pauses.

  4. Change in dysfluency of speech using a Phonetics Software [ Time Frame: After 3 months of each intervention ]
    Sample speeches will be recorded and digitalized at 44,000Hz using a microphone and analyzed ina Phonetics software. Dysfluency is calculated as percentage of dysfluent words/total number of words. Dysfluent words are defined as part-words, word or phrase repetitions, revisions, hesitations or fillers.

  5. Change in intelligibility of speech using a Phonetics Software [ Time Frame: After 3 months of each intervention ]
    Sample speeches will be recorded and digitalized at 44,000Hz using a microphone and analyzed in a Phonetics software. Intelligibility is a subjective measure of speech quality, and will be measured by a single rater trained in speech-language pathology.

  6. Change in the Movement Disorders sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS), a measure of various motor and non-motor symptoms used to assess the clinical course of Parkinson's longitudinally. [ Time Frame: After 3 months of each intervention ]
    The MDS-UPDRS scores range from 0 to 272, with higher scores meaning more severe disease

  7. Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI) [ Time Frame: After 3 months of each intervention ]
    The BDI is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Scores range from 0 to 63, with higher scores meaning worse depression.

  8. Walking speed measured with the Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Walking speed will be measured.

  9. Step length measured with the Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of step length will be measured.

  10. Double support time measured with the Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of double support time will be measured. The double support time is the the time during gait where both feet are in contact to the ground

  11. Cadence measured with the Zeno Walkway [ Time Frame: After 3 months of each intervention ]
    The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of cadence will be measured. Cadence is the number of steps per minute of walking.

  12. Percentage of ON time without troublesome dyskinesias during waking hours [ Time Frame: After 3 months of each intervention ]
    ON time without dyskinesias is defined as the period of time is which patients have good mobility, associated with a good response to treatments and without troublesome involuntary movements (dyskinesias). This will be measured as percentage of ON time during the waking hours of the day, Patients will complete 24-hours motor diaries during 3 consecutive days, in which they are asked to rate their motor functions every 30 minutes.

  13. Number of falls or near-falls [ Time Frame: Collected after 3 months of each intervention, but assessing all intervention period, averaging 6 months ]
    Participants will be asked to keep track of all falls and near-falls (an event in which a person feels a fall is imminent but avoids it by compensatory action, such as grabbing a nearby object or controlling the fall) on a written diary throughout the intervention period.

  14. Change in levodopa equivalent daily dose (LEDD) [ Time Frame: After 3 months of each intervention ]
    LEDD is calculated using a conversion formula to transform all medications used for treatment of Parkinson's disease to an equivalent dose of levodopa

  15. Measure of resting-state local field potentials and functional connectivity of the brain using magnetoencephalography (MEG) [ Time Frame: After 3 months of each intervention ]
    MEG will be used to measure the average absolute power and the power spectrum density of neuronal activity of the brain, both measures will be used to assess the effect of deep brain stimulation on the functional activity and oscillatory synchronization of various movement-related areas of the brain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093544


Locations
Layout table for location information
Canada, Ontario
Movement disorders Centre, Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alfonso Fasano, MD, PhD    +1 416 603 5800 ext 5961    alfonso.fasano@uhn.ca   
Sponsors and Collaborators
University of Toronto
Investigators
Layout table for investigator information
Principal Investigator: Alfonso Fasano, MD University of Toronto
Publications:

Layout table for additonal information
Responsible Party: Alfonso Fasano, Professor of Neurology, University of Toronto
ClinicalTrials.gov Identifier: NCT04093544    
Other Study ID Numbers: 17-5705
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Alfonso Fasano, University of Toronto:
deep brain stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases