Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316232
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-01
Brief Title:
DBS and Levodopa for Treating Freezing of Gait in Parkinsons Disease
Sponsor:
IRCCS Istituto delle Scienze Neurologiche di Bologna
Organization:
IRCCS Istituto delle Scienze Neurologiche di Bologna
Study Overview
Official Title:
Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinsons Disease a Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Freezing of gait FoG is a complex symptom of Parkinsons 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
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
Detailed 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 Parkinsons 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
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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None