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Biomarkers to Guide Directional DBS for Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03353688
Recruitment Status : Recruiting
First Posted : November 27, 2017
Last Update Posted : November 15, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Harrison Walker, MD, University of Alabama at Birmingham

Brief Summary:
The purpose of this study is to investigate the clinical efficacy of directional DBS electrode technology and whether electrophysiology biomarkers can predict effective contact segments for chronic therapy.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Boston Scientific Vercise PC IPG with directional DBS lead Not Applicable

Detailed Description:
Although deep brain stimulation (DBS) can be remarkable for treating symptoms of Parkinson's disease, improvement varies across clinical trials, individual patients, and over time. A major limitation to the advancement of DBS therapy is that there are no established biomarkers to tailor stimulator settings in individuals. Emerging segmented ("directional") lead technology allows current steering, a new opportunity to improve tolerability and efficacy by shaping the DBS electrical field. This novel lead design has 8 contacts rather than the 4 available with currently available leads. How do the investigators optimally adjust stimulation parameters when there are far more potentially useful settings than can be practically evaluated in clinic? How do the investigators know that DBS settings in a given patient are optimal or appropriate? The investigators have pioneered minimally invasive, rapidly acquired biomarkers to solve these important problems. Using electrocorticography, electroencephalography, and subcortical local field potentials, the investigators will measure whether resting or stimulus-evoked electrophysiology can serve as a predictive biomarker to guide activation and adjustment of a directional DBS system. The purpose of this randomized, double-blind crossover study is to measure the clinical efficacy of directional versus omnidirectional stimulation and to explore whether electrophysiology biomarkers can rapidly predict effective, well-tolerated contacts for directional DBS therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a triple blind, randomized crossover study of directional versus omnidirectional unilateral subthalamic deep brain stimulation for Parkinson's disease with motor fluctuations.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This is a triple blind study. Participants, raters, and investigator are masked to the assignment of directional versus omnidirectional unilateral subthalamic deep brain stimulation guided by behavioral programming for Parkinson's disease with motor fluctuations. For the nested exploratory arm evaluating directional DBS guided by electrophysiology biomarkers, the study is double-blind (investigator is not blinded).
Primary Purpose: Treatment
Official Title: Noninvasive Biomarkers to Advance Emerging DBS Electrode Technologies in Parkinson's Disease
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Directional DBS guided by behavior
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Device: Boston Scientific Vercise PC IPG with directional DBS lead
Deep brain stimulation

Placebo Comparator: Omnidirectional DBS guided by behavior
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Device: Boston Scientific Vercise PC IPG with directional DBS lead
Deep brain stimulation

Active Comparator: Directional DBS guided by biomarkers
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Device: Boston Scientific Vercise PC IPG with directional DBS lead
Deep brain stimulation




Primary Outcome Measures :
  1. Change from preoperative baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "off" medications [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    A blinded examiner will measure MDS-UPDRS part 3 motor scores "off" medications with directional versus omnidirectional unilateral subthalamic brain stimulation. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates each motor symptom based on a scale of 0 - 4, higher values indicating worse function.

  2. Treatment Preference Survey [ Time Frame: 4 months after surgery ]
    Based on overall quality of life, participants will select their preference between directional and omnidirectional DBS.


Secondary Outcome Measures :
  1. Change from preoperative baseline in NIH Toolbox Cognition Battery [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition.

  2. Change from preoperative baseline in the Beck Depression Inventory-2 (BDI-2) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The BDI-2 is a self-report inventory which evaluates a person's severity of depression.

  3. Change from preoperative baseline in the Beck Anxiety Inventory (BAI) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The BAI is a self-report inventory which evaluates a person's severity of anxiety.

  4. Change from preoperative baseline in the Conners Continuous Performance Test Third Edition (Conners CPT-3) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The Conners CPT-3 evaluates attention-related performance in areas of inattentiveness, impulsivity, sustained attention, and vigilance.

  5. Change from preoperative baseline in the Auditory Verbal Learning Test (AVLT) (versions AB, CD, CR, GE) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The AVLT (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information.

  6. Change from preoperative baseline in the 10/36 Spatial Recall Test (forms 1,2 ,3, 4) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The 10/36 Spatial Recall Test (forms 1, 2 ,3, 4) evaluates visuospatial memory.

  7. Change from preoperative baseline in the Letter Fluency Test (version: CFL, FAS) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The Letter Fluency Test (version: CFL, FAS) evaluates the number of words beginning with the letters C, F, L, A, and S that a participant can produce in one minute.

  8. Change from preoperative baseline in the D-KEFS Color-Word Interference Test (CWIT) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The CWIT consists of four parts (color naming, word reading, inhibition, and inhibition/switching) and evaluates the ability to inhibit a dominant and automatic verbal response.

  9. Change from preoperative baseline in the Neuropsychiatric Inventory [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The Neuropsychiatric Inventory evaluates cognitive function by assessing delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, and aberrant motor behavior.

  10. Change from preoperative baseline in the Rainbow Passage [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The phonetically-balanced Rainbow Passage evaluates speech function by assessing the ability to produce connected speech by measuring average intensity, average fundamental frequency, duration, and cepstral measure of the second sentence.

  11. Change from preoperative baseline in Spontaneous Speech Production [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The Spontaneous Speech Production measure evaluates speech function by assessing the ability to produce spontaneous speech by measuring average intensity, average fundamental frequency, and speech production/articulation.

  12. Change from preoperative baseline in Acoustic Measures [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The acoustic measures evaluate spontaneous speech, maximum phonation time, and voicing formants F1 and F2.

  13. Change from preoperative baseline in the Voice Handicap Index [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The Voice Handicap Index evaluates speech function with a 30-item self-administered questionnaire that asks participants to describe their voice and the effects of their voice on their lives.

  14. Change from preoperative baseline in the Communicative Participation Item Bank (CPIB) [ Time Frame: Preoperative baseline and 2, 4, and 6 months after surgery ]
    The CPIB evaluates the extent to which communication disorders interfere with communicative participation.

  15. Change from preoperative baseline in the Movement Disorders Society Unified Parkinson's Disease Rating Scale (UPDRS) Version 3 Part I [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    MDS-UPDRS part I is a scale of 13 summed items, which assesses the impact of Parkinson's disease on experiences of daily living. Part 1A is administered by the investigator (6 items) and focuses on complex behaviors. Part 1B is part of the self-administered participant questionnaire that covers 7 items on non-motor experiences of daily living. Each item is rated based on a scale of 0 - 4, higher values indicating worse function.

  16. Change from preoperative baseline in the Movement Disorders Society Unified Parkinson's Disease Rating Scale (UPDRS) Version 3 Part II [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    MDS-UPDRS II is a self-evaluated questionnaire of 20 summed items in which the participants answer questions about experiences of daily living. Each item is rated based on a scale of 0 - 4, higher values indicating worse function.

  17. Change from preoperative baseline in the Movement Disorders Society Unified Parkinson's Disease Rating Scale (UPDRS) Version 3 Part IV [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    MDS-UPDRS IV evaluates complications of therapy, where the investigator uses historical and objective information to assess two motor complications, dyskinesias and motor fluctuations that include OFF-state dystonia. The scale consists of 6 summed items, where each item is rated based on a scale of 0 - 4, higher values indicating worse function.

  18. Change from preoperative baseline in Activities-Specific Balance Confidence (ABC) Scale [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The ABC Scale is a self-report measure that evaluates a person's confidence in performing various ambulatory activities without falling.

  19. Change from preoperative baseline in the Freezing of Gait Questionnaire (FOG-Q) [ Time Frame: Preoperative baseline, 3-5 weeks after surgery, and 2, 4, 6, and 12 months after surgery ]
    The FOG-Q evaluates a person's freezing of gait, a gait disturbance which interrupts walking. The questionnaire consists of 6 summed items; each item is rated based on a scale of 0 - 4, higher values indicating worse function.

  20. Change from preoperative baseline in the 9-Hole Pegboard Test [ Time Frame: Preoperative baseline, 3-5 weeks after surgery, and 2, 4, 6, and 12 months after surgery ]
    The 9-Hole Pegboard Test evaluates one's upper extremity motor function.

  21. Change from preoperative baseline in the Time to Walk Test [ Time Frame: Preoperative baseline, 3-5 weeks after surgery, and 2, 4, 6, and 12 months after surgery ]
    In the Time to Walk Test, individuals will be timed while they walk 6m at either their comfortable or fastest safe speed.

  22. Change from preoperative baseline in Gait Initiation Test [ Time Frame: Preoperative baseline, 3-5 weeks after surgery, and 2, 4, 6, and 12 months after surgery ]
    The gait initiation test evaluates the phase between standing motionless and steady-state locomotion.

  23. Change from preoperative baseline in Stepping Thresholds Test [ Time Frame: Preoperative baseline, 3-5 weeks after surgery, and 2, 4, 6, and 12 months after surgery ]
    The stepping thresholds test evaluates a person's compensatory stepping thresholds.

  24. Change from preoperative baseline in Quiet Stance Measure [ Time Frame: Preoperative baseline, 3-5 weeks after surgery, and 2, 4, 6, and 12 months after surgery ]
    The quiet stance measure evaluates a person's postural control during quiet standing.

  25. Change from preoperative baseline in the Parkinson's Disease Quality of Life Questionnaire short form (PDQ-8) [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PDQ-8 evaluates overall health status consisting of eight questions regarding mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.

  26. Change from preoperative baseline in the the Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form evaluates feelings that reflect a level of general satisfaction with life as well as a sense that life has purpose and meaning.

  27. Change from preoperative baseline in the Neuro-QOL Item Bank v1.1 "Satisfaction with Social Roles and Activities" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The Neuro-QOL Item Bank v1.1 "Satisfaction with Social Roles and Activities" short form short form evaluates one's satisfaction and discontentment with performing usual social roles and activities.

  28. Change from preoperative baseline in the Neuro-QOL Item Bank v2.0 "Cognitive Function" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The Neuro-QOL Item Bank v2.0 ""Cognitive Function" short form evaluates mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions.

  29. Change from preoperative baseline in the Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" short form evaluates functioning of one's lower extremities.

  30. Change from preoperative baseline in the Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" short form evaluates functioning of one's upper extremity function in fine motor and ADL capabilities.

  31. Change from preoperative baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 "Global Health" [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The (PROMIS) Scale v1.2 "Global Health" evaluates one's overall physical and mental health.

  32. Change from preoperative baseline in the Neuro-QOL Item Bank v1.0 "Stigma" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The Neuro-QOL Item Bank v1.0 "Stigma" short form evaluates one's sensitivity of illness-related stigma.

  33. Change from preoperative baseline in the Neuro-QOL Scale v1.0 "Communication" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The Neuro-QOL Scale v1.0 "Communication" short form evaluates one's difficulty with communication.

  34. Change from preoperative baseline in the Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" short form evaluates one's confidence to manage/control symptoms of frustration, disappointment, anger, and other negative emotions.

  35. Change from preoperative baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Ability to Participate in Social Roles and Activities" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PROMIS v2.0 "Ability to Participate in Social Roles and Activities" short form evaluates one's perceived ability to perform one's usual social roles and activities.

  36. Change from preoperative baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Anxiety" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PROMIS v1.0 "Emotional Distress - Anxiety" short form evaluates one's feelings of anxiety, such as fear and worry.

  37. Change from preoperative baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Depression" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PROMIS v1.0 "Emotional Distress - Depression" short form evaluates one's feelings of negative mood and depression.

  38. Change from preoperative baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Fatigue" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PROMIS v1.0 "Fatigue" short form evaluates one's range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.

  39. Change from preoperative baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Physical Function" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PROMIS v2.0 "Physical Function" short form measures self-reported capability rather than actual performance of physical activities

  40. Change from preoperative baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Pain Interference" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PROMIS v1.0 "Pain Interference" short form evaluates the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.

  41. Change from preoperative baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Sleep Disturbance" short form [ Time Frame: Preoperative baseline and 2, 4, 6, and 12 months after surgery ]
    The PROMIS v1.0 "Sleep Disturbance" short form evaluates one's perceptions of sleep quality.



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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years and ≤70 years.
  2. Clinically definite, advanced idiopathic PD based on at least 2 of 3 cardinal PD features (tremor, rigidity, or bradykinesia).
  3. Disease duration of 4 years or more.
  4. Participant has elected to undergo DBS surgery as part of routine care, and the subthalamic nucleus (STN) is recommended as the surgical target.
  5. Participant agrees to not undergo contralateral DBS for the other side of the brain until ≥ 12 months after initial DBS surgery.
  6. Participant is healthy enough to undergo surgery and the research protocol.
  7. Normal, or essentially normal, preoperative brain MRI.
  8. Willingness and ability to cooperate during awake DBS surgery, as well as during post-operative evaluations, adjustments of medications and stimulator settings.
  9. Participant's health insurance and/or Medicare covers DBS surgery as part of routine care.
  10. Refractory motor symptoms such as tremor, dyskinesias, wearing off, and/or motor fluctuations, causing significant disability or occupational dysfunction, despite reasonable attempts at medical management, as determined by our consensus DBS committee.
  11. Stable doses of PD medications for at least 28 days prior to baseline assessments.
  12. Improvement of motor signs ≥30% with dopaminergic medication as assessed with the use of the Movement Disorders - Unified Parkinson's Disease Rating Scale, part III (MDS-UPDRS III; scores range from 0 to 108, with higher scores indicating worse functioning).
  13. Disease severity ratings above Hoehn and Yahr stage 1, defined as unilateral involvement only with minimal or no functional disability, with scores ranging from 0 to 5 and higher scores indicating more severe disease.
  14. Score of more than 6 for activities of daily living in the worst "off" medication condition despite medical treatment, as assessed with the use of the MDS-UPDRS II (scores range from 0 to 52, with higher scores indicating worse functioning), or mild-to-moderate impairment in social and occupational functioning (score of 51 to 80% on the Social and Occupational Functioning Assessment Scale with scores ranging from 1 to 100 and lower scores indicating worse functioning).
  15. Dementia Rating Scale-2 (DRS-2) score of ≥130 on medications.
  16. Beck Depression Inventory II (BDI-II) score of ≤25 on medications.
  17. Participant expresses understanding of the consent process, terms of the study protocol, is available for follow-up over the length of the study, and signs informed consent.

Exclusion Criteria:

  1. Age <18 years or >70 years.
  2. Participant's insurance will not cover the costs of surgery with the investigational device.
  3. Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation.
  4. Duration of disease of <4 years
  5. Participant or care team determine that contralateral DBS for the other side of the brain will likely be clinically indicated <12 months after initial DBS surgery.
  6. Diagnosis or suspicion of atypical parkinsonism (progressive supranuclear palsy, multiple system atrophy, corticobasal syndrome) or drug-induced parkinsonism, or significant neurological disease other than Parkinson's disease.
  7. Disease severity ratings of Hoehn and Yahr stage 1, defined as unilateral involvement only with minimal or no functional disability, with scores ranging from 0 to 5 and higher scores indicating more severe disease.
  8. Diagnosis of psychogenic movement disorder based on consensus criteria.
  9. Score of >25 on the Beck Depression Inventory II, with scores ranging from 0 to 63 and higher scores indicating worse functioning), or history of suicide attempt.
  10. Any current acute psychosis, alcohol abuse or drug abuse.
  11. Clinical dementia (score of ≤130 on the Mattis Dementia Rating Scale with scores ranging from 0 to 144 and higher scores indicating better functioning).
  12. Ongoing or pervasive impulse control disorder not resolved by reduction of dopaminergic medications.
  13. Use of anticoagulant medications that cannot be discontinued during perioperative period.
  14. History of hemorrhagic stroke.
  15. Current or future risk of immunocompromise that might significantly increase risk of infection.
  16. History of recurrent of unprovoked seizures.
  17. Lack of clear levodopa responsiveness.
  18. Any medical condition requiring repeated MRI.
  19. The presence of an implanted device (e.g., cochlear implant, pacemaker, neurostimulators), whether turned on or off.
  20. Prior DBS surgery or ablation within the affected basal ganglion.
  21. A condition requiring or likely to require the use of diathermy.
  22. Structural lesions such as basal ganglionic stroke, tumor or vascular malformation as etiology of the movement disorder.
  23. Any medical or psychological problem that would interfere with the conduction of the study protocol
  24. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

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): NCT03353688


Contacts
Contact: Tesia Pair, BS 2059349459 tpair@uabmc.edu
Contact: Chris L Gonzalez, MS 2059753732 clg17@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Harrison Walker, MD         
Principal Investigator: Harrison Walker, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Harrison Walker, MD University of Alabama at Birmingham

Responsible Party: Harrison Walker, MD, Associate Professor of Neurology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03353688     History of Changes
Other Study ID Numbers: IRB-161018001
1UH3NS100553-01 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share data through the BRAIN Initiative data sharing consortium.
Supporting Materials: Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will be made available after analyses of the primary and secondary outcomes.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Harrison Walker, MD, University of Alabama at Birmingham:
Parkinson's
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases