Asymmetric Subthalamic Deep Brain Stimulation for Axial Motor Dysfunction in Parkinson's Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-14

Study Completion Date

2019-04-15

Brief Summary

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This single-center, randomized, quadruple-blinded, double-crossover comparative efficacy trial will study the effects of unilateral 50% voltage reduction in axial motor dysfunction for patients with Parkinson's disease that develop treatment-resistant postural stability gait dysfunction after bilateral subthalamic nucleus deep brain stimulation surgery.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Baseline STN-DBS

Maintenance of baseline bilateral STN-DBS settings.

Group Type NO_INTERVENTION

No interventions assigned to this group

Asymmetric STN-DBS 1

Unilateral 50% reduction of voltage (e.g. right side)

Group Type EXPERIMENTAL

Asymmetric STN-DBS

Intervention Type OTHER

Asymmetric deep brain stimulation

Asymmetric STN-DBS 2

Unilateral 50% reduction of voltage (e.g. left side)

Group Type EXPERIMENTAL

Asymmetric STN-DBS

Intervention Type OTHER

Asymmetric deep brain stimulation

Interventions

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Asymmetric STN-DBS

Asymmetric deep brain stimulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with Parkinson's disease (PD) (previously diagnosed according to the UK brain bank criteria) who develop treatment-resistant postural instability gait dysfunction (PIGD) more than 6 months but less than 5 years after bilateral subthalamic nucleus deep brain stimulation (STN-DBS).
* Treatment-resistant PIGD will be defined as freezing of gait and UPDRS or MDS-UPDRS PIGD subscales of more than 6 points despite optimization of medications and bilateral STN-DBS programming.

Exclusion Criteria

* Treatment-resistant PIGD less than 6 months or more than 5 years after STN-DBS surgery.
* PIGD responsive to optimization of medications and/or bilateral STN-DBS programming.
* Cognitive impairment or psychiatric comorbidities (including substance abuse) that would interfere with the informed consent process, study adherence or outcome assessments.
* Advanced PD or any other neurological, cardiovascular or musculoskeletal co-morbidities that would preclude or require assistance to complete the 10-meter walking test.
* Patients not able to comply with 4-week interval evaluations following their potential enrollment due to personal reasons.
* Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically-stable on therapy, in the opinion of the site investigator, for at least 30 days prior to study entry.
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Eligible Sex

ALL

Accepts Healthy Volunteers

No