Parkinson Disease Clinical Trial
Official title:
Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Istituto delle Scienze Neurologiche di Bologna | Bologna |
Lead Sponsor | Collaborator |
---|---|
IRCCS Istituto delle Scienze Neurologiche di Bologna | Azienda Ospedaliera Città della Salute e della Scienza di Torino |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Gait performance | Changes in gait parameters measured by a system of 3 wearable inertial sensors, including: gait speed, stride lenght, number of step, cadence, gait variability, left-right asymmetry during MED ON plus or STIM ON plus protocol compared to baseline. | immediate post monitoring | |
Secondary | MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III | Change in items 3.10 and 3.11 MDS UPDRS part III and total score between MED ON plus or STIM ON plus condition and baseline. | immediate post monitoring | |
Secondary | Patient global impression of change (PGI-C) | Change in PGI-C scores on MED ON plus or STIM ON plus condition compared to baseline. | immediate post monitoring | |
Secondary | Trail Making test A and B | Change in Trail Making test A and B scores during MED ON plus or STIM ON plus protocol compared to baseline. | immediate post monitoring | |
Secondary | Phonemic/Semantic alternate Fluency test | Change in during Phonemic/Semantic alternate Fluency test scores between MED ON plus or STIM ON plus condition and baseline. | immediate post monitoring |
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