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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06316232
Other study ID # DBS-FOG 2023
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 10, 2023
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source IRCCS Istituto delle Scienze Neurologiche di Bologna
Contact Ilaria Cani
Phone 0039 051 4966959
Email ilaria.cani@studio.unibo.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
STIM ON plus
increase of intensity of stimulation of 0.5 mA bilaterally
Drug:
MED ON plus
administration of a 2x levodopa morning dose

Locations

Country Name City State
Italy IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna

Sponsors (2)

Lead Sponsor Collaborator
IRCCS Istituto delle Scienze Neurologiche di Bologna Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

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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