Cycling Deep Brain Stimulation on Parkinson's Disease Gait

Parkinson Disease Clinical Trial

— DBS  

Official title:

Effects of Cycling Deep Brain Stimulation on Parkinson's Disease Gait

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408573
• Other study ID #: 67914017.6.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: December 29, 2021

Study information

• Verified date: June 2020
• Source: University of Sao Paulo General Hospital
• Contact: Rubens G Cury, MD, PhD
• Phone: 55 11 26617877
• Email: rubens_cury[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our hypothesis is that cycling DBS stimulation would be superior or non-inferior to regular DBS stimulation in Parkinson's disease patients with gait impairment. The objective of this study is compare gait disorders in patients with Parkinson's disease and DBS in 4 different scenarios: 1) regular continuous high frequency (>130Hz) stimulation, 2) cycling high frequency (>130Hz) stimulation (40sec on, 2sec off), 3) low-frequency (80Hz) continuous stimulation and 4) cycling low frequency (80Hz) stimulation (40sec on, 2sec off)

Description:

Gait disorders such as falls, freezing of gait, reduction of speed, shuffling, and multi-stepped turning are common in patients with moderate and advanced Parkinson's disease. Compared to appendicular symptoms (bradykinesia, tremor, and rigidity), gait disorders tend to be more resistant to medical and regular deep brain stimulation treatment, and greatly impairs patients' quality of life and daily living activities. Some stimulation strategies have been tried to improve gait in Parkinson's disease patients, but so far most of them resulted in concomitant worsening of appendicular symptoms. However, new stimulation strategies such as cycling stimulation can potentially improve gait disorders without impairment of appendicular symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 29, 2021
• Est. primary completion date: May 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's disease

• Currently receiving Deep Brain Stimulation as a Parkinson's disease treatment

• Hoehn & Yahr stage between 2-4 during off-medication

• Underlying gait disorders despite optimal medical and stimulation treatment: score over or equal to 1 in the subitem 2.12 of the MDS-UPDRS scale

• Willingness to comply with all study procedures

Exclusion Criteria:

• Active moderate/severe psychiatric condition

• Active infection or other uncontrolled moderate/grave comorbidities

• Treatment with experimental drug

• Pregnancy or breast-feeding

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Cycling deep brain stimulation
Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the part II of the Unified Parkinson's disease rating scale	The part II of the Unified Parkinson's disease rating scale (UPDRS II) is a self-reportable questionnaire consisting of 13 items that measure functionality (motor experiences of daily living). Scores vary from 0 - 52. Higher scores mean a worse outcome.	Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Primary	Change in the New Freezing of Gait Questionnaire	The New Freezing of Gait Questionnaire (NFOG-Q) is a self-reportable questionnaire consisting of 9 items that measure freezing of gait (FOG). Scores vary from 0 - 28. Higher scores mean a worse outcome.	Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Secondary	Change in Falls Efficacy Scale	The Falls Efficacy Scale (FES) is a sixteen-item test rated on a 10-point scale from not confident at all to completely confident. It is correlated with difficulty getting up from a fall and level of anxiety. Scores vary from 16 - 64. Higher scores mean a worse outcome.	Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Secondary	Change in The Parkinson's Disease Questionnaire (PDQ-39)	This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure.Scores vary from 0 - 156. Higher scores mean a worse outcome.	Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Secondary	Change in Activities-Specific Balance Confidence Scale (ABC scale)	The ABC scale is a self-report measure of balance in performing various activities without losing balance or experiencing a sense of unsteadiness. Scores vary from 0 - 100. Higher scores mean a better outcome.	Baseline + after 2 weeks + after 4 weeks + after 6 weeks
Secondary	Number of falls	Patients will be questioned about number of times they experienced falls in the last 2 weeks. Higher numbers mean a worse outcome.	Baseline + after 2 weeks + after 4 weeks + after 6 weeks