Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna
RECRUITING
Bologna
Contact Information
Primary
Ilaria Cani
ilaria.cani@studio.unibo.it
0039 051 4966959
Backup
Giulia Giannini
giulia.giannini15@unibo.it
0039 051 4966959
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Active_comparator: 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)
Active_comparator: 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)
Sponsors
Collaborators: A.O.U. Città della Salute e della Scienza
Leads: IRCCS Istituto delle Scienze Neurologiche di Bologna

This content was sourced from clinicaltrials.gov