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Parkinson DiseaseNCT03582891

The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy

A study testing Summit RC+S for Motor, 8-week pilot trial of Closed-loop vs. Open-loop Stimulation and Summit RC+S for Sleep in people with Parkinson Disease and Dystonia, run by University of California, San Francisco at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Parkinson Disease, Dystonia
What is being tested?
Summit RC+S for Motor, 8-week pilot trial of Closed-loop vs. Open-loop Stimulation and Summit RC+S for Sleep
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Parkinson's Disease:
  • Ability to give informed consent for the study
  • Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
  • Patient has requested surgical intervention with deep brain stimulation for their disorder
  • No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
  • Absence of significant cognitive impairment (score of 20 or greater on the Montreal Cognitive Assessment (MoCA),
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  • Signed informed consent
  • Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
  • Age 21-75 (for STN patients, minimum age is 25)
  • Diagnosis of idiopathic PD with duration of motor symptoms for 4 years or greater
  • Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist, and has had stable doses of antiparkinsonian medications for 30 days prior to baseline assessment.
  • UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia.
  • OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management
  • Dystonia:
  • Ability to give informed consent for the study
  • Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
  • Patient has requested surgical intervention with deep brain stimulation for their disorder
  • No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
  • Absence of significant cognitive impairment (score of 20 or greater on the Montreal Cognitive Assessment (MoCA)
  • Signed informed consent
  • Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
  • Age 21-75
  • Diagnosis of Isolated dystonia, which may be focal cervical, segmental craniocervical, or generalized forms.
  • Stable doses of anti-dystonia medications (such as trihexyphenydil, Baclofen, or clonazepam) for at least 30 days prior to baseline assessment
  • For dystonia patients with craniofacial and cervical involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.

Who cannot join

  • Parkinson's Disease:
  • Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
  • Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
  • Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
  • Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
  • Any personality or mood symptoms that study personnel believe will interfere with study requirements.
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  • Subjects who require ECT, rTMS or diathermy
  • Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator, neurostimulator or metallic implant
  • Previous cranial surgery
  • Drug or alcohol abuse
  • Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are: performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests.
  • Dystonia:
  • Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
  • Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
  • Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
  • Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
  • Any personality or mood symptoms that study personnel believe will interfere with study requirements.
  • Subjects who require ECT, rTMS or diathermy
  • Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator, neurostimulator or metallic implant
  • Previous cranial surgery
  • Drug or alcohol abuse

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California at San Francisco

    San Francisco, California, 94115

Other trials in United States

About this study

Official title: Closed Loop Deep Brain Stimulation in Parkinson's Disease and Dystonia (Activa RC+S)

This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S.

This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.

Read the detailed description

In this project investigators will develop adaptive DBS algorithms based on cortical and subcortical signals using the RC+S. This bidirectional neural interface is rechargeable (for up to 9 years of use), and is capable of delivering therapeutic open-loop stimulation or closed-loop stimulation. Its sensing capability includes four simultaneous time series channels at up to 1000 Hz sampling rate. In addition the device can stream time series data, and calculate and stream spectral power within a preset bandwidth. Twenty patients with idiopathic PD and motor fluctuations, or medically intractable tremor, will be implanted with unilateral or bilateral RC+S devices, each connected to a standard quadripolar DBS lead implanted in STN or globus pallidus, and to a 4-contact paddle type electrode placed subdurally over sensorimotor cortex. The basal ganglia lead will be used for both stimulation and LFP recordings, while the cortical lead will be used only for recording ECoG potentials, not for stimulation.

Patients with motor fluctuations cycle between a hypokinetic state (too little movement) and a hyperkinetic state (excessive movement). During open-loop DBS, brain state continues to fluctuate between these states and stimulation may induce dyskinesia or inadequately relieve akinesia.

With the goal of maintaining motor function within a normal range away from these two extremes, investigators will develop and test stimulation algorithms that utilize putative markers of both kinetic states. Investigators will also study neural signals of sleep and test stimulation to support specific sleep stages. The basic strategy is to automatically adjust stimulation parameters until the physiological signature of abnormal function is minimized. First, investigators will prototype adaptive stimulation paradigms and briefly (2 hours) test them in clinic, using a "distributed" configuration (streaming to a computer). Then, investigators will embed these algorithms in RC+S to test chronic and fully closed-loop DBS in a small double-blinded clinical trial. Investigators will pay careful attention to the possibility of progressive reduction in stimulation currents over the course of the study, which could support the hypothesis that "adaptive stimulation" might make the brain progressively less dependent on the device. In quantifying DBS amplitude and comparing open loop with adaptive stimulation, an important parameter is the total electrical energy delivered (TEED). TEED is calculated by the following equation as suggested by Koss and colleagues (TEED1sec = ((voltage2 x frequency x pulsewidth)/impedance) x 1sec). This can be used as measure of the energy saved when stimulation is delivered in closed-loop mode relative to empiric open-loop stimulation.

Being tested
Summit RC+S for Motor, 8-week pilot trial of Closed-loop vs. Open-loop Stimulation, Summit RC+S for Sleep
Medical subject headings
Parkinson Disease, Dystonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Summit RC+S for MotorDevice

    Using the RC+S pulse generator, investigators will measure cortical biomarkers of hyper and hypokinesia in Parkinson's and dystonia patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology.

  • 8-week pilot trial of Closed-loop vs. Open-loop StimulationDiagnostic test

    These patients will participate in an 8 week clinical trial of open loop versus adaptive mode (4 weeks for each mode (interleaved), with the order counterbalanced across subjects ).

  • Summit RC+S for SleepDevice

    Also called Sleep

    Using the RC+S pulse generator, investigators will measure cortical biomarkers of sleep stages in Parkinson's patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology.

Study groups in NCT03582891
Study groupRoleWhat they receive
Parkinson's Disease STN TargetOtherParkinson's disease patients implanted in STN
Receives: Device: Summit RC+S for Motor; Diagnostic Test: 8-week pilot trial of Closed-loop vs. Open-loop Stimulation; Device: Summit RC+S for Sleep
Parkinson's disease patients GP TargetOtherParkinson's disease patients implanted in Globus Pallidus
Receives: Device: Summit RC+S for Motor; Diagnostic Test: 8-week pilot trial of Closed-loop vs. Open-loop Stimulation; Device: Summit RC+S for Sleep
Dystonia patientsOtherIsolated dystonia patients
Receives: Device: Summit RC+S for Motor; Diagnostic Test: 8-week pilot trial of Closed-loop vs. Open-loop Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of 'on' stimulation time without dyskinesia from motor diaries in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)

    Duration of 'on' stimulation time without dyskinesia in adaptive compared to standard open loop stimulation determined from the patients' motor diaries. The self-report motor diary is a validated method to capture this information. Every half-hour, patients indicate in this diary which of 4 categories (on, on with troubling dyskinesia, off, or asleep) best reflected their predominant symptoms for the prior 30 minutes. Patients will complete this diary for 3 consecutive days. The total time spent in the 'on' state without troubling dyskinesia will then be summed and averaged over 3 days for all three conditions (baseline, open-loop stimulation and closed-loop stimulation).

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  2. The Burke-Fahn-Marsden Dystonia Rating Scale-Movement aDBS testing compared to pre-operative baseline(Dystonia Patients)

    This scales evaluates dystonia in nine body areas, including eyes, mouth, speech and swallowing, neck, trunk, and right and left arm and leg. The maximal total score is 120 - a higher score means worsening symptoms. Investigators will compare the dystonia symptoms and functional disability during adaptive stimulation compared to preoperative baseline.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  3. Toronto Western Spasmodic Torticollis Rating Scale during aDBS testing compared to pre-operative baseline (Dystonia Patients)

    This is a standardized scale to measure the severity, disability, and pain associated with cervical dystonia. The motor severity subscale consists of 10 items, with variable scaling and weighting. It also includes a disability scale with six items,and a pain scale with three items. The total score is the sum of each of the subscales. A higher score indicates greater disability.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  4. Karolinska Sleepiness Scale

    This is a standardized scale for measuring sleepiness

    Measured: Through study completion, up to 4 years

  5. Psychomotor vigilance task (PVT)

    This is a standardized behavioral task for measure alertness and attention

    Measured: Through study completion, up to 4 years

  6. Positive and Negative Affect Schedule (PANAS-SF)

    This is a standardized mood questionnaire

    Measured: Through study completion, up to 4 years

Secondary outcomes (9)

  1. The Unified Parkinsons Disease Rating Scale (UPDRS) III scores off of medication in adaptive compared to standard open-loop stimulation. (Parkinson's disease patients)

    The UPDRS III is a motor rating scale. Investigators will compare the severity motor symptoms while the patient is off of Parkinsoniae (UPDRS) III scores off of medication in adaptive compared to standard open-loop stimulation. (Parkinson's disease patients)n medications in conventional (open-loop) versus adaptive (closed-loop) DBS.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  2. Schwab England scale in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)

    This scale estimates the abilities of individuals living with Parkinson's Disease relative to a completely independent situation. Investigators will use it to compare the abilities of daily living in subjects during the open-loop and adaptive stimulation trial.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  3. Hoehn and Yahr Staging in the medication 'on' state in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)

    The Hoehn and Yahr scale are used to describe the progression of Parkinson's disease based upon the level of motor impairment. This scale only includes one score ranging from 1 to 5 where a higher score indicates a higher level of motor impairment. Investigators will compare the level of disease progression between the open-loop and adaptive stimulation conditions.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  4. The patient' quality of life report (PDQ-39) in adaptive compared to standard open loop stimulation. The PDQ39 yields a score between 0 to 100, where a higher score indicates more health problems. (Parkinson's disease patients)

    The PDQ 39 questionnaire has 39 questions to assess the patient's life quality including mobility, emotional state, and bodily comfort. Investigators will make a comparison of patients' life quality of life between open-loop and adaptive stimulation.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  5. Patient's Global Impression of Change (PGIC) in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)

    Patient Global Impression of Changes measures the self-reported level of overall improvement (motor and non-motor symptoms) in a patient on a 1-7 scale. A one indicates no change and a 7 is the greatest level of improvement.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  6. Total Electric Energy Delivered (TEED) by the pulse generator in adaptive compared to standard open loop stimulation. (all patients)

    Investigators will compare the total charge delivered by the pulse generator between open-loop and adaptive stimulation to determine if there is a potential energy savings.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  7. Short form 36 Quality of Life measure (Dystonia Patients)

    The SF-36 is a measure of self-reported health status which is scored on a 0-100 scale. The lower the score the more disability a patient experiences.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  8. Patient Global Impression of Change (Dystonia Patients)

    Patient Global Impression of Changes measures the self-reported level of overall improvement (motor and non-motor symptoms) in a patient on a 1-7 scale. A one indicates no change and a 7 is the greatest level of improvement.

    Measured: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.

  9. Resting state EEG Recording

    Resting state cortical power will be analyzed as a surrogate marker of alertness

    Measured: Through study completion, up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2025
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Investigators will run a pilot clinical trial in which individualized classifier/control strategies for each hemisphere in each subject will be embedded within the RC+S for a total of one month (x4 one week blocks) of feedback-controlled stimulation will be compared with a total of one month of empirically optimized open-loop stimulation, (x4 one week blocks), administered in randomized order with adaptive stimulation. During these 1-month trials, patients and neurologists will be blinded to the state of the stimulator.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03582891
Sponsor's protocol ID
UCSF Summit RC+S
Status last verified
Jun 2026
First submitted
14 Jun 2018
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Oehrn CR, Cernera S, Hammer LH, Shcherbakova M, Yao J, Hahn A, Wang S, Ostrem JL, Little S, Starr PA. Chronic adaptive deep brain stimulation versus conventional stimulation in Parkinson's disease: a blinded randomized feasibility trial. Nat Med. 2024 Nov;30(11):3345-3356. doi: 10.1038/s41591-024-03196-z. Epub 2024 Aug 19.

    PubMed 39160351

  • Louie KH, Gilron R, Yaroshinsky MS, Morrison MA, Choi J, de Hemptinne C, Little S, Starr PA, Wang DD. Cortico-Subthalamic Field Potentials Support Classification of the Natural Gait Cycle in Parkinson's Disease and Reveal Individualized Spectral Signatures. eNeuro. 2022 Nov 11;9(6):ENEURO.0325-22.2022. doi: 10.1523/ENEURO.0325-22.2022. Print 2022 Nov-Dec.

    PubMed 36270803

  • Powell MP, Anso J, Gilron R, Provenza NR, Allawala AB, Sliva DD, Bijanki KR, Oswalt D, Adkinson J, Pouratian N, Sheth SA, Goodman WK, Jones SR, Starr PA, Borton DA. NeuroDAC: an open-source arbitrary biosignal waveform generator. J Neural Eng. 2021 Feb 5;18(1):10.1088/1741-2552/abc7f0. doi: 10.1088/1741-2552/abc7f0.

    PubMed 33152715

Questions about this trial

What is this clinical trial studying?

A study testing Summit RC+S for Motor, 8-week pilot trial of Closed-loop vs. Open-loop Stimulation and Summit RC+S for Sleep in people with Parkinson Disease and Dystonia, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of 'on' stimulation time without dyskinesia from motor diaries in adaptive compared to standard open loop stimulation. (Parkinson's disease patients) (time frame: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03582891, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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