DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2026-12-31

Brief Summary

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Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS.

In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa.

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Detailed Description

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This is a cross-over, blind, randomized study to evaluate the improvement of FoG in a group of PD patients treated with bilateral STN-DBS by increasing the intensity of stimulation (STIM plus) or administering a higher dose of levodopa (MED plus).

Patient will be videorecorded for evaluation of freezing episodes and gait cinematic parameters by means of 3 wearable inertial sensors on the feet and at lumbar level during a standardized walking protocol including: Timed Up and Go, Turn 360°, Gait 18 m and a Complex task in single task and dual task (serial-3 subtractions) conditions. In each condition, Tinetti scale, Trail Making Test, alternate fluency test, Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) and MDS Unified Dyskinesia Rating Scale (UDysRS) will be also perform.

In addition, other demographic and clinical information such as age, sex, MMSE, MoCA, New Freezing of Gait Questionnaire, Falls Efficacy Scale will be collected.

The primary endpoint of this study is to investigate the efficacy of increasing intensity of stimulation (STIM plus) or levodopa (MED plus) on freezing of gait (FOG).

Secondary outcome measures include cinematic gait parameters, global motor outcomes and cognitive functions.

Conditions

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Freezing of Gait Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In addition to baseline gait assessment performed in a morning session on MED ON/STIM ON condition (after usual levodopa morning dose and usual parameters of stimulation), patients are evaluated in two following morning sessions under different treatment conditions:

1. STIM ON plus: evaluation after the administration of levodopa morning dose and the increase of intensity of stimulation of 0.5 mA bilaterally,
2. MED ON plus: evaluation after the administration of a 2x levodopa morning dose with usual parameters of stimulation.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The count and duration of FoG episodes during the standardize walking protocol is measured on video-assessment by two blind raters.

Study Groups

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STIM ON plus/MED ON plus

Patients were evaluated in two following morning sessions under different treatment conditions:

1. STIM ON plus (intervention 1)
2. MED ON plus (intervention 2)

Group Type ACTIVE_COMPARATOR

STIM ON plus

Intervention Type DEVICE

increase of intensity of stimulation of 0.5 mA bilaterally

MED ON plus

Intervention Type DRUG

administration of a 2x levodopa morning dose

MED ON plus/STIM ON plus

Patients were evaluated in two following morning sessions under different treatment conditions:

1. MED ON plus (intervention 2)
2. STIM ON plus (intervention 1)

Group Type ACTIVE_COMPARATOR

STIM ON plus

Intervention Type DEVICE

increase of intensity of stimulation of 0.5 mA bilaterally

MED ON plus

Intervention Type DRUG

administration of a 2x levodopa morning dose

Interventions

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STIM ON plus

increase of intensity of stimulation of 0.5 mA bilaterally

Intervention Type DEVICE

MED ON plus

administration of a 2x levodopa morning dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with Parkinson's disease treated with STN-DBS who achieved a good control of motor fluctuations and cardinal motor symptoms (bradykinesia, rigidity, tremor)
* History of FoG in daily-ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and score ≥ 2 on Question 2 of the New Freezing of Gait Questionnaire.

Exclusion Criteria

* inability to walk independently for 10 meters.
* limited therapeutic windows of stimulation without the possibility of increase the intensity of stimulation of 0,5 mA for the appearance of side effects
* previous evidence of severe adverse effects with high levodopa dose ore increased STN-DBS intensity, such as psychosis, hallucinations, painful dyskinesias, severe hypotension, digestive symptoms.
* dementia (MMSE score ≤ 18)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No