Adults 18 to 70, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Preoperative Baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "Off" MedicationsPrimary· 2, 4, and 6 months post op
A blinded examiner will measure Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates the severity of Parkinson's motor symptoms based on a scale of 0 - 4. Higher values indicate worse function (possible min score = 0, possible max score = 72).
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - perfo
Group
Value
95% CI
Directional DBS Guided by Behavior
-16.90322581
± 9.253305135
Omnidirectional DBS Guided by Behavior
-15.80645161
± 9.257139064
Directional DBS Guided by Biomarkers
-18.33333333
± 9.848274252
Treatment Preference Survey Programming Strategy PreferencePrimary· 4 months post surgery
Based on overall quality of life, participants will select their preference between directional and omnidirectional DBS.
Group
Value
95% CI
Directional DBS Guided by Behavior
16
Omnidirectional DBS Guided by Behavior
14
Change From Preoperative Baseline in the Beck Depression Inventory-2 (BDI-2)Secondary· 2, 4, and 6 months post op
The Beck Depression Inventory-2 is a 21 question self-report inventory which evaluates a person's severity of depression. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63).
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Group
Value
95% CI
Directional DBS Guided by Behavior
0.965517241
± 6.455798936
Omnidirectional DBS Guided by Behavior
1.032258065
± 5.056242814
Directional DBS Guided by Biomarkers
0.692307692
± 6.739550316
Change From Preoperative Baseline in the Beck Anxiety Inventory (BAI)Secondary· 2, 4, and 6 months post op
The Beck Anxiety Inventory is a 21 question self-report inventory which evaluates a person's severity of anxiety. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63).
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Group
Value
95% CI
Directional DBS Guided by Behavior
-2.55
± 5.689093906
Omnidirectional DBS Guided by Behavior
-0.333333333
± 6.32455532
Directional DBS Guided by Biomarkers
-0.6875
± 8.16266909
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Delayed Recall Raw Score (Versions AB, CD, CR, GE)Secondary· 2, 4, and 6 months post op
The Auditory Verbal Learning Test (AVLT) delayed recall raw score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and later asked to recall the items on the list. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 12).
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, base
Group
Value
95% CI
Directional DBS Guided by Behavior
-0.866666667
± 3.785027976
Omnidirectional DBS Guided by Behavior
-0.9
± 3.39726056
Directional DBS Guided by Biomarkers
-0.461538462
± 3.776037809
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Recognition Raw Score (Versions AB, CD, CR, GE)Secondary· 2, 4, and 6 months post op
The Auditory Verbal Learning Test (AVLT) Recognition Raw Score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are given a list of 15 target words. The list is taken away and each is asked to now pick out the 15 target words from a larger list of 30 words. Scores indicate the overall number of target words correctly recognized (minimum = 0, maximum = 15). Higher scores indicate better performance.
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation i
Group
Value
95% CI
Directional DBS Guided by Behavior
-0.5
± 1.696853071
Omnidirectional DBS Guided by Behavior
-0.433333333
± 1.59056124
Directional DBS Guided by Biomarkers
-0.961538462
± 1.482720991
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Learning Raw Score (Versions AB, CD, CR, GE)Secondary· 2, 4, and 6 months post op
The AVLT (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and asked to immediately recall the items on the list over 6 separate trials. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 72).
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on
Group
Value
95% CI
Directional DBS Guided by Behavior
-2.233333333
± 9.772174901
Omnidirectional DBS Guided by Behavior
-3.3
± 9.203260292
Directional DBS Guided by Biomarkers
-0.576923077
± 8.276100903
Change From Preoperative Baseline in the Letter Fluency Test Raw Score (Version: CFL, FAS)Secondary· 2, 4, and 6 months post op
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 (minimum = 0, maximum = infinity). Higher scores indicate better function.
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Group
Value
95% CI
Directional DBS Guided by Behavior
-1.766666667
± 8.21975473
Omnidirectional DBS Guided by Behavior
-1.935483871
± 9.401898687
Directional DBS Guided by Biomarkers
-1.230769231
± 9.074393389
Change From Preoperative Baseline in the Voice Handicap IndexSecondary· 2, 4, and 6 months post op
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. Participants respond on a 0 - 4 scale (minimum = 0, maximum = 120. Higher scores indicate worse functiion.
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directio
Group
Value
95% CI
Directional DBS Guided by Behavior
-2.709677419
± 9.256325939
Omnidirectional DBS Guided by Behavior
0.225806452
± 7.774786931
Directional DBS Guided by Biomarkers
-0.925925926
± 12.04135798
Change From Preoperative Baseline in the Communicative Participation Item Bank (CPIB)Secondary· 2, 4, and 6 months post op
The Communicative Participation Item Bank (CPIB) evaluates the extent to which communication disorders interfere with communicative participation. Participants respond on a 0 - 3 scale (minimum = 0, maximum = 30). Higher scores indicate better function.
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Group
Value
95% CI
Directional DBS Guided by Behavior
-0.387096774
± 3.489769996
Omnidirectional DBS Guided by Behavior
-0.741935484
± 2.920818857
Directional DBS Guided by Biomarkers
-0.740740741
± 4.927103944
Change From Preoperative Baseline in the 9-Hole Pegboard TestSecondary· 2, 4, and 6 months post op
The 9-Hole Pegboard Test evaluates one's upper extremity motor function. It is a timed test in which participants place 9 pegs in a pegboard and then remove them. Faster times indicate better function.
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Group
Value
95% CI
Directional DBS Guided by Behavior
-6.15
± 10.86369404
Omnidirectional DBS Guided by Behavior
-5.242258065
± 11.16955019
Directional DBS Guided by Biomarkers
-6.755
± 11.38578962
Change From Preoperative Baseline in Gait Initiation TestSecondary· 2, 4, and 6 months post op
The gait initiation test evaluates the phase between standing motionless and steady-state locomotion. This is a timed test in which participants are given a go signal and the time until first stride is recorded. Faster times indicate better function.
A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Group
Value
95% CI
Directional DBS Guided by Behavior
5.810333333
± 22.17604991
Omnidirectional DBS Guided by Behavior
2.491
± 22.48954996
Directional DBS Guided by Biomarkers
2.282
± 27.67356219
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Alabama at Birmingham
Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03353688.