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

NCT06316232 | Recruiting Phase 4

• 1 other identifier: DBS-FOG 2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Freezing of Gait; Parkinson Disease

Keywords

freezing of gait; gait disturbances; parkinson disease

Outcome Measures

Primary Outcomes (1)

• Time spent with FOG during protocol

  Video-assessed reduction in the total time of FoG during the standardize walking protocol in MED ON plus or STIM ON plus condition compared to baseline.

  immediate post monitoring

Secondary Outcomes (5)

• Gait performance

  immediate post monitoring

• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III

  immediate post monitoring

• Patient global impression of change (PGI-C)

  immediate post monitoring

• Trail Making test A and B

  immediate post monitoring

• Phonemic/Semantic alternate Fluency test

  immediate post monitoring

Study Arms (2)

STIM ON plus/MED ON plus

ACTIVE COMPARATOR

Patients were evaluated in two following morning sessions under different treatment conditions: 1. STIM ON plus (intervention 1) 2. MED ON plus (intervention 2)

Device: STIM ON plus; Drug: MED ON plus

MED ON plus/STIM ON plus

ACTIVE COMPARATOR

Patients were evaluated in two following morning sessions under different treatment conditions: 1. MED ON plus (intervention 2) 2. STIM ON plus (intervention 1)

Device: STIM ON plus; Drug: MED ON plus

Interventions

STIM ON plus DEVICE

increase of intensity of stimulation of 0.5 mA bilaterally

MED ON plus/STIM ON plus; STIM ON plus/MED ON plus

MED ON plus DRUG

administration of a 2x levodopa morning dose

MED ON plus/STIM ON plus; STIM ON plus/MED ON plus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Istituto delle Scienze Neurologiche di Bologna: lead
• A.O.U. Città della Salute e della Scienza: collaborator

Study Sites (1)

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, 40139, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilaria Cani

  IRCCS Istituto delle Scienze Neurologiche di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Cani

CONTACT

0039 051 4966959; ilaria.cani@studio.unibo.it

Giulia Giannini

CONTACT

0039 051 4966959; giulia.giannini15@unibo.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The count and duration of FoG episodes during the standardize walking protocol is measured on video-assessment by two blind raters.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 18, 2024
• Study Start: October 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)