Parkinson DiseaseNCT04093544
Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads
A study testing Deep brain stimulation in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
Trial summary
Exploring directional lead Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
- 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)
- 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.
- Patients aged 18 to 80 years.
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Movement disorders Centre, Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Alfonso Fasano, MD, PhD, +1 416 603 5800 ext. 5961, alfonso.fasano@uhn.ca
About this study
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
Exploring directional lead
Read the detailed description
This is a single-centre, double-blinded cross-over study comparing the standard electrode configuration (ring-mode) vs. directional electrode configuration for steered stimulation of deep brain stimulation (DBS) patients.
The study will follow 2 phases.
Phase 1:
Visit 1 Screening/Baseline (T0):
As per current standard care for patients undergoing subthalamic deep brain stimulation (STN-DBS), participants will be screened 3-6 months before the DBS STN implant surgery (T0) according to the inclusion/exclusion criteria.
Visits for standard practiced care for programing of DBS Between 1 to 3 months after the surgery, programing of the DBS system for the 20 patients will be done in an open label fashion in order to find the contact able to reduce the motor symptoms without the side effects. This will be done according to the standard of practice currently adopted at Toronto Western Hospital.
Phase 2:
Visit 1
Randomization: 4 months +/- 4weeks after the surgery, patients will be randomized to two type of stimulation:
- Standard : The percentage of current allocated to the central split contacts will be evenly distributed in order to perfectly mimic a standard ring contact. All possible types of frequencies and pulse widths will be used. The same amount of current for each of the active contacts will be used.
- Directional: contacts 1-8 will be used in any possible configuration and using different amount of current for each of the active one as well as different frequencies. In conclusion, all the capabilities of the DBS system will be used.
Possible adjustments to stimulation parameters (e.g. pulse width, amplitude threshold) will be performed to achieve an optimal therapeutic window for each patient.
Visit 2 Follow up visit at 6 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 3 (T1):
Cross over : 7 months +/- 4 weeks after the surgery patients will be switched to the other type of stimulation . Raters and patients will be blinded to the group allocation.
Visit 4:
Follow up visit at 9 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 5 (T2):
End of study visit at month 10 +/- 4 weeks after the surgery. There might be unscheduled visits in case of unexpected clinical conditions (i.e. occurrence of side effects or worsening of motor conditions). Participants will be in this study for a maximum of 16 months. Throughout the whole study, participants will visit the clinic without their regular medication as part of standard treatment practice. All the stimulation adjustment will be performed by the same unblinded physician or sub-investigator.
- Conditions
- Parkinson Disease
- Being tested
- Deep brain stimulation
- Keywords
- deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationDevice
Steered stimulation using directional leads
| Study group | Role | What they receive |
|---|---|---|
| Standard Stimulation | Active comparator | Participants will receive stimulation using the best contact combination in ring mode. Receives: Device: Deep brain stimulation |
| Directional Stimulation | Experimental | Participants will receive stimulation using the best segmented (steered) contacts. Receives: Device: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number/incidence of adverse events
Number/incidence of adverse events
Measured: Throughout the study, averaging 6 months
Secondary outcomes (15)
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)
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.
Measured: After 3 months of each intervention
Patients Global Impression of Change (PGIC)
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.
Measured: After 3 months of each intervention
Change in articulation rate of speech using a Phonetics Software
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.
Measured: After 3 months of each intervention
Change in dysfluency of speech using a Phonetics Software
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.
Measured: After 3 months of each intervention
Change in intelligibility of speech using a Phonetics Software
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.
Measured: After 3 months of each intervention
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.
The MDS-UPDRS scores range from 0 to 272, with higher scores meaning more severe disease
Measured: After 3 months of each intervention
Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI)
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.
Measured: After 3 months of each intervention
Walking speed measured with the Zeno Walkway
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.
Measured: After 3 months of each intervention
Step length measured with the Zeno Walkway
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.
Measured: After 3 months of each intervention
Double support time measured with the Zeno Walkway
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
Measured: After 3 months of each intervention
Cadence measured with the Zeno Walkway
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.
Measured: After 3 months of each intervention
Percentage of ON time without troublesome dyskinesias during waking hours
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.
Measured: After 3 months of each intervention
Number of falls or near-falls
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.
Measured: Collected after 3 months of each intervention, but assessing all intervention period, averaging 6 months
Change in levodopa equivalent daily dose (LEDD)
LEDD is calculated using a conversion formula to transform all medications used for treatment of Parkinson's disease to an equivalent dose of levodopa
Measured: After 3 months of each intervention
Measure of resting-state local field potentials and functional connectivity of the brain using magnetoencephalography (MEG)
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.
Measured: After 3 months of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start15 May 2018
- Primary completion15 May 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fasano, University of Toronto
- Investigators
- Alfonso Fasano, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093544
- Sponsor's protocol ID
- 17-5705
- Status last verified
- Sep 2019
- First submitted
- 7 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fasano A, Daniele A, Albanese A. Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Lancet Neurol. 2012 May;11(5):429-42. doi: 10.1016/S1474-4422(12)70049-2.
PubMed 22516078Herzog J, Pinsker M, Wasner M, Steigerwald F, Wailke S, Deuschl G, Volkmann J. Stimulation of subthalamic fibre tracts reduces dyskinesias in STN-DBS. Mov Disord. 2007 Apr 15;22(5):679-84. doi: 10.1002/mds.21387.
PubMed 17266046Barbe MT, Maarouf M, Alesch F, Timmermann L. Multiple source current steering--a novel deep brain stimulation concept for customized programming in a Parkinson's disease patient. Parkinsonism Relat Disord. 2014 Apr;20(4):471-3. doi: 10.1016/j.parkreldis.2013.07.021. Epub 2013 Sep 14. No abstract available.
PubMed 24041939Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.
PubMed 26027940Contarino MF, Bour LJ, Verhagen R, Lourens MA, de Bie RM, van den Munckhof P, Schuurman PR. Directional steering: A novel approach to deep brain stimulation. Neurology. 2014 Sep 23;83(13):1163-9. doi: 10.1212/WNL.0000000000000823. Epub 2014 Aug 22.
PubMed 25150285Steigerwald F, Muller L, Johannes S, Matthies C, Volkmann J. Directional deep brain stimulation of the subthalamic nucleus: A pilot study using a novel neurostimulation device. Mov Disord. 2016 Aug;31(8):1240-3. doi: 10.1002/mds.26669. Epub 2016 May 31.
PubMed 27241197Pollo C, Kaelin-Lang A, Oertel MF, Stieglitz L, Taub E, Fuhr P, Lozano AM, Raabe A, Schupbach M. Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain. 2014 Jul;137(Pt 7):2015-26. doi: 10.1093/brain/awu102. Epub 2014 May 19.
PubMed 24844728
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04093544
- Acronym / sponsor ID
- 17-5705
- Conditions
- Parkinson Disease
- Keywords
- deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 15 May 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exploring directional lead
Detailed description
This is a single-centre, double-blinded cross-over study comparing the standard electrode configuration (ring-mode) vs. directional electrode configuration for steered stimulation of deep brain stimulation (DBS) patients.
The study will follow 2 phases.
Phase 1:
Visit 1 Screening/Baseline (T0):
As per current standard care for patients undergoing subthalamic deep brain stimulation (STN-DBS), participants will be screened 3-6 months before the DBS STN implant surgery (T0) according to the inclusion/exclusion criteria.
Visits for standard practiced care for programing of DBS Between 1 to 3 months after the surgery, programing of the DBS system for the 20 patients will be done in an open label fashion in order to find the contact able to reduce the motor symptoms without the side effects. This will be done according to the standard of practice currently adopted at Toronto Western Hospital.
Phase 2:
Visit 1
Randomization: 4 months +/- 4weeks after the surgery, patients will be randomized to two type of stimulation:
- Standard : The percentage of current allocated to the central split contacts will be evenly distributed in order to perfectly mimic a standard ring contact. All possible types of frequencies and pulse widths will be used. The same amount of current for each of the active contacts will be used.
- Directional: contacts 1-8 will be used in any possible configuration and using different amount of current for each of the active one as well as different frequencies. In conclusion, all the capabilities of the DBS system will be used.
Possible adjustments to stimulation parameters (e.g. pulse width, amplitude threshold) will be performed to achieve an optimal therapeutic window for each patient.
Visit 2 Follow up visit at 6 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 3 (T1):
Cross over : 7 months +/- 4 weeks after the surgery patients will be switched to the other type of stimulation . Raters and patients will be blinded to the group allocation.
Visit 4:
Follow up visit at 9 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 5 (T2):
End of study visit at month 10 +/- 4 weeks after the surgery. There might be unscheduled visits in case of unexpected clinical conditions (i.e. occurrence of side effects or worsening of motor conditions). Participants will be in this study for a maximum of 16 months. Throughout the whole study, participants will visit the clinic without their regular medication as part of standard treatment practice. All the stimulation adjustment will be performed by the same unblinded physician or sub-investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Stimulation | Active comparator | Device: Deep brain stimulationParticipants will receive stimulation using the best contact combination in ring mode. |
| Directional Stimulation | Experimental | Device: Deep brain stimulationParticipants will receive stimulation using the best segmented (steered) contacts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulationSteered stimulation using directional leads | Device | Directional Stimulation, Standard Stimulation |
Primary outcome
Number/incidence of adverse events
Time frame: Throughout the study, averaging 6 months
Number/incidence of adverse events
15 secondary outcomes
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
Patients Global Impression of Change (PGIC)
Time frame: After 3 months of each intervention
Change in articulation rate of speech using a Phonetics Software
Time frame: After 3 months of each intervention
Change in dysfluency of speech using a Phonetics Software
Time frame: After 3 months of each intervention
Change in intelligibility of speech using a Phonetics Software
Time frame: After 3 months of each intervention
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
Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI)
Time frame: After 3 months of each intervention
Walking speed measured with the Zeno Walkway
Time frame: After 3 months of each intervention
Step length measured with the Zeno Walkway
Time frame: After 3 months of each intervention
Double support time measured with the Zeno Walkway
Time frame: After 3 months of each intervention
Cadence measured with the Zeno Walkway
Time frame: After 3 months of each intervention
Percentage of ON time without troublesome dyskinesias during waking hours
Time frame: After 3 months of each intervention
Number of falls or near-falls
Time frame: Collected after 3 months of each intervention, but assessing all intervention period, averaging 6 months
Change in levodopa equivalent daily dose (LEDD)
Time frame: After 3 months of each intervention
Measure of resting-state local field potentials and functional connectivity of the brain using magnetoencephalography (MEG)
Time frame: After 3 months of each intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Background: PubMed 22516078Fasano A, Daniele A, Albanese A. Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Lancet Neurol. 2012 May;11(5):429-42. doi: 10.1016/S1474-4422(12)70049-2.
- Background: PubMed 17266046Herzog J, Pinsker M, Wasner M, Steigerwald F, Wailke S, Deuschl G, Volkmann J. Stimulation of subthalamic fibre tracts reduces dyskinesias in STN-DBS. Mov Disord. 2007 Apr 15;22(5):679-84. doi: 10.1002/mds.21387.
- Background: PubMed 24041939Barbe MT, Maarouf M, Alesch F, Timmermann L. Multiple source current steering--a novel deep brain stimulation concept for customized programming in a Parkinson's disease patient. Parkinsonism Relat Disord. 2014 Apr;20(4):471-3. doi: 10.1016/j.parkreldis.2013.07.021. Epub 2013 Sep 14. No abstract available.
- Background: PubMed 26027940Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.
- Background: PubMed 25150285Contarino MF, Bour LJ, Verhagen R, Lourens MA, de Bie RM, van den Munckhof P, Schuurman PR. Directional steering: A novel approach to deep brain stimulation. Neurology. 2014 Sep 23;83(13):1163-9. doi: 10.1212/WNL.0000000000000823. Epub 2014 Aug 22.
- Background: PubMed 27241197Steigerwald F, Muller L, Johannes S, Matthies C, Volkmann J. Directional deep brain stimulation of the subthalamic nucleus: A pilot study using a novel neurostimulation device. Mov Disord. 2016 Aug;31(8):1240-3. doi: 10.1002/mds.26669. Epub 2016 May 31.
- Background: PubMed 24844728Pollo C, Kaelin-Lang A, Oertel MF, Stieglitz L, Taub E, Fuhr P, Lozano AM, Raabe A, Schupbach M. Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain. 2014 Jul;137(Pt 7):2015-26. doi: 10.1093/brain/awu102. Epub 2014 May 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Movement disorders Centre, Toronto Western Hospital
Toronto, Canada
Alfonso Fasano, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation in people with Parkinson Disease, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number/incidence of adverse events (time frame: Throughout the study, averaging 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093544, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.