Cycling Deep Brain Stimulation on Parkinson's Disease Gait (DBS)

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Parkinson Disease

Treatments: Other: Cycling deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04408573

67914017.6.0000.0068

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 4 patient groups

Regular Continuous High Frequency

No Intervention group

Description:

Patient remains 2 weeks in the currently chosen stimulation protocol.

Cycling High Frequency

Experimental group

Description:

Patient is stimulated with the same polarity, voltage/current, pulse width and frequency as the currently chosen stimulation protocol, but with cycling stimulation: 40sec On - 02 sec OFF

Treatment:

Other: Cycling deep brain stimulation

Continuous Low Frequency

Experimental group

Description:

Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz). Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.

Treatment:

Other: Cycling deep brain stimulation

Cycling Low Frequency

Experimental group

Description:

Patient is stimulated with the same polarity and pulse width as the currently chosen stimulation protocol, but with low frequency (80Hz) and cycling stimulation: 40sec On - 02 sec OFF. Voltage/current will be adjusted to maintain TEED similar to that on the regular stimulation protocol.

Treatment:

Other: Cycling deep brain stimulation