NCT Number: NCT06316232
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 4
Bologna, 40139, Italy
Location status: Recruiting
Carlo Alberto Artusi, MD, PhD
SUB_INVESTIGATOR
Giovanna Calandra Buonaura, MD, PhD
SUB_INVESTIGATOR
Giulia Giannini
CONTACT
Giulia Giannini, MD, PhD
PRINCIPAL_INVESTIGATOR
Ilaria Cani
CONTACT
Ilaria Cani, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
increase of intensity of stimulation of 0.5 mA bilaterally
administration of a 2x levodopa morning dose
Time frame: immediate post monitoring
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.
Time frame: immediate post monitoring
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.
Time frame: immediate post monitoring
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.
Time frame: immediate post monitoring
Change in PGI-C scores on MED ON plus or STIM ON plus condition compared to baseline.
Time frame: immediate post monitoring
Change in Trail Making test A and B scores during MED ON plus or STIM ON plus protocol compared to baseline.
Time frame: immediate post monitoring
Change in during Phonemic/Semantic alternate Fluency test scores between MED ON plus or STIM ON plus condition and baseline.
Contact information is provided by the study sponsor or research team.
Giulia Giannini
CONTACT
Ilaria Cani
CONTACT
IRCCS Istituto delle Scienze Neurologiche di Bologna
Other
Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
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