Trial Outcomes & Findings for Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology (NCT NCT03409120)

Last Updated: 2022-11-10

Results Overview

Evaluation of degree of dystonia related symptoms. Domains evaluated include eyes, mouth, speech/swallowing, neck, arms, trunk, and legs. Each domain is scored on degree of provoking factor (0= no dystonia at rest or with action; 4 = dystonia present at rest) and severity factor (0 = no dystonia; 4 = extreme/severe dystonia). Scores are then weighted yielding a total score between 0 and 120. Higher scores on the scale indicate greater disease severity.

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

5 minutes

Results posted on

2022-11-10

Participant Flow

Participants were recruited and studied prospectively as part of the SUNDIAL (SUbthalamic Nucleus DIrectionAL stimulation) study, a randomized, double-blind crossover study contrasting directional versus circular unilateral STN DBS for PD (FDA Investigational Device Exemption G-170063). Further details on inclusion/exclusion are outlined at https://clinicaltrials.gov/ct2/show/NCT03353688.

All subjects provided written informed consent prior to participation with approval from the institutional review board. We included data from all consecutively enrolled participants. Dystonia status was not part of the enrollment criteria.

Participant milestones

Participant milestones
Measure	Dystonia Severity Assessment We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline. Boston Scientific Vercise PC IPG with directional DBS lead: We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Unlocking Dystonia From Parkinson's Disease With Directional DBS Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Patients Enrolled in Study n=38 Participants All patients enrolled in the study
Age, Continuous	49.0 years STANDARD_DEVIATION 13.2 • n=99 Participants
Sex: Female, Male Female	12 Participants n=99 Participants
Sex: Female, Male Male	26 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	34 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Burke-Fahn-Marsden Total Dystonia Scale	3.5 units on a scale STANDARD_DEVIATION 6.0 • n=99 Participants

PRIMARY outcome

Timeframe: 5 minutes

Population: We analyzed data from all enrolled participants

Outcome measures

Outcome measures
Measure	Study Patients Enrolled in Study n=38 Participants All patients enrolled in the study
Burke-Fahn-Marsden Dystonia Rating Scale	3.5 units on a scale Standard Deviation 6.0

Adverse Events

Dystonia Severity Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher Gonzalez

University of Alabama at Birmingham

Phone: 2059753732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place