Automated Mechanical Peripheral Stimulation to Treat Freezing of Gait in Patients With Parkinson's Disease and STN-DBS (AMBITION)

Gondola Medical Technologies

Status: Unknown

Conditions: Gait Disorders, Neurologic; Parkinson Disease

Treatments: Device: GONDOLA AMPS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04831879

UKK - AMBITION

Details and patient eligibility

About

The objective is to investigate whether AMPS (Automated Mechanical Peripheral Stimulation) is effective in reduction of FOG measured via the FOG-AC (Freezing Of Gait Assessment Course) in people with Parkinson Disease and STN-DBS (Subthalamic Nucleus Deep Brain Stimulation) in a randomized, double-blind, sham-controlled, cross-over trial

Full description

The effects of AMPS treatment (effective vs sham) will be measured using the FOG-AC assessment. Patients will be randomized to receive either AMPS treatment and then sham or sham and then AMPS. Each treatment phase will be 4 weeks of treatment, separated by a 6-week washout period.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• ≥18 years old
• Diagnosis of Parkinson's Disease according to the United Kingdom Brain Bank Criteria
• Bilateral STN-DBS for at least 6 months
• Moderate to severe FOG i.e. FOG-AC ≥8 pts.

Exclusion criteria

• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Pregnancy
• Enrolment of the investigator, his/her family members, employees and other dependent persons,
• L-Dopa induced-freezing (defined by medical history),
• DBS-induced freezing (defined by medical history),
• Clinically relevant depression
• Clinically relevant cognitive impairments
• Shoe size greater than 46

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Group A AMPS - sham

Experimental group

Description:

Treatment phase 1: AMPS Treatment phase 2: sham

Treatment:

Device: GONDOLA AMPS

Group B sham - AMPS

Experimental group

Description:

Treatment phase 1: sham Treatment phase 2: AMPS

Treatment:

Device: GONDOLA AMPS