Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

Deep Brain Innovations

Status: Terminated

Conditions: Parkinson Disease

Treatments: Device: TOPS2 DBS; Device: TOPS3 DBS; Device: TOPS1 DBS; Device: Standard DBS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04390867

0152

Details and patient eligibility

About

This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purpose of this study is to determine if TOPS DBS can improve Parkinson's symptoms compared to Standard DBS.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosed with Parkinson's disease
• Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's disease at least 6 months prior to the study date
• Responds to DBS by having demonstrated a minimum improvement in motor score

Key Exclusion Criteria:

• Score of <24 on the Mini Mental Status Exam
• Abuses drugs or alcohol
• Pregnant
• History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other neurological disorders (i.e. epilepsy, stroke)
• Prisoners, employees that report to investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 4 patient groups

TOPS1 DBS

Experimental group

Description:

Participants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order.

Treatment:

Device: TOPS3 DBS

Device: Standard DBS

Device: TOPS1 DBS

Device: TOPS2 DBS

TOPS2 DBS

Experimental group

Description:

Participants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order.

Treatment:

Device: TOPS3 DBS

Device: Standard DBS

Device: TOPS1 DBS

Device: TOPS2 DBS

TOPS3 DBS

Experimental group

Description:

Participants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order.

Treatment:

Device: TOPS3 DBS

Device: Standard DBS

Device: TOPS1 DBS

Device: TOPS2 DBS

Standard DBS

Active Comparator group

Description:

Participants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.

Treatment:

Device: TOPS3 DBS

Device: Standard DBS

Device: TOPS1 DBS

Device: TOPS2 DBS