Coordinated Reset Deep Brain Stimulation for Parkinson's Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Minnesota
About this trial
Deep brain stimulation (DBS) is a surgical implant procedure for the treatment of Parkinson's Disease (PD) utilizing medical devices approved by the FDA. A novel approach to current DBS approaches is called "Coordinated Reset" DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude and high frequency stimulation. This study will evaluate the safety and short-term efficacy of CR-DBS in PD. The results from this study will significantly advance the development of CR-DBS for the treatment of PD. Findings in this study will also provide the rationale for further development of this novel DBS approach for other neurological and psychiatric disorders.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Idiopathic Parkinson's Disease
Minimum age of 21 years old
Will be or has been implanted with the Boston Scientific Vercise Genus Rechargeable DBS system
Disqualifiers
History of musculoskeletal disorders that affect movement of the limbs/gait
Other significant neurological disorder
Significant psychiatric disorder
History of dementia or cognitive impairment that precludes them from getting DBS surgery or per study staff judgment, MacCAT-CR assessment does not deduce that the participant has capacity to consent
Trial design
Design model
Crossover
Treatments tested in this trial
DBS
DeviceDeep Brain Stimulation
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: CR-DBSActive comparator 1 intervention
Group B: T-DBSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
The MDS-UPDRS is a standard rating scale for PD that has been widely used in clinical settings and PD research. It utilizes a 4-subscale structure and 5-point (Normal = 0 to Severe = 4) severity scale. Part III of the Scale assesses the motor signs of PD through 18 items, with a maximum possible score of 72.
Time frame
Through participant study completion, an average of two monthsSecondary outcomes
1
Frequency and Severity of Bradykinesia, Dyskinesia, Tremor, Sleep Quality and Fragmentation Scores Measured via KinetiGraph.
The KinetiGraph PKG system consists of a small watch-device worn on the wrist for collecting data over a period of several days and provides a report that shows how motor symptoms and complications of PD such as bradykinesia, tremor and dyskinesias vary throughout the day. The watch will be worn on the patient's most affected side (indicated by each patient's MDS-UPDRS III scores for two body sides).
Time frame
Through participant study completion, an average of two months2
Amplitude Decrement via Rapid Alternating Movements (RAMs)
This task assesses hypokinesia and the sequence effect (deterioration of movement amplitude over time). Pronation-supination movements will be performed using a forearm manipulandum. Movement will be visually guided and acoustically paced. Four 60-second trials will be completed each side (right and left arms), with each trial including 4 transitions in movement rate (1.0 or 1.75 Hz). Delsys inertial measurement units (IMUs) will also be used during this task to measure EMG and kinematic data.
Time frame
Through participant study completion, an average of two months3
Forearm Rigidity
Forearm rigidity will be assessed using a custom-built robotic manipulandum which provides reliable and objective measures of resistance to imposed motion. The device passively imposes sinusoidal movements of the forearm about the pronation-supination axis through a ± 40° range of motion at 1.5 Hz while measuring the angular displacement and resistive torque required to move the limb. Trials will be collected separately for the right and left arms, with or without an activation maneuver (tapping the contralateral hand on the leg), a technique that is used clinically to elicit or enhance rigidity. Delsys inertial measurement units (IMUs) will be used to measure the EMG activities of biceps brachii and pronator teres muscles, as secondary measurements during the task.
Time frame
Through participant study completion, an average of two months4
Cognitive Measurements (TMT-B)
Trail Making Task-B will evaluate visual scanning, sequencing, cognitive flexibility and processing speed will be completed.
Time frame
Through participant study completion, an average of two monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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