Condition: Movement disorders
Key Inclusion Criteria:
- Scheduled for a new implant or implantable pulse generator device replacement surgery with a market-released Abbott DBS system within 3 months
Key Exclusion Criteria:
- Currently enrolled or plans to enroll in another concurrent study that may confound (confuse) the results of this clinical investigation
- Has anatomic or comorbid (occurring at the same time) conditions, or other medical, social, or psychological conditions that could limit ability to participate in the clinical investigation or comply with follow-up requirements, or impact the soundness of results
Abbott DBS Registry of Outcomes for Indications over Time (IRB no. 00000625)
This data collection study focuses on individuals who are scheduled to receive an Abbott Deep Brain Stimulation (DBS) systems implant to help treat their movement disorder.
DBS therapy uses small electrical pulses at a specific area within the brain to treat movement disorder. It requires an operation to place thin wires with electrodes in the brain and to connect the electrodes to a battery. The implanted system includes an implantable pulse generator (IPG) that holds the battery and electrical components that generate the stimulation pulses; a thin wire with electrodes; and an extension that carries the stimulation pulses from the IPG to the electrodes.
The Abbott DBS systems used in this study have been approved by the Food and Drug Administration (FDA). The study will allow Abbott to continue to monitor the approved devices for a period of up to five years.