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Parkinson's Disease (PD)NCT07213999

Novel DBS Device in Parkinson's Disease

A study testing Novel neural recorder in people with Parkinson's Disease (PD), run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research is to test a new recorder that can measure brain activity when stimulation is turned on during deep brain stimulation (DBS) surgery. To continue to improve DBS therapy, the investigators need to better understand the changes in the brain of people with Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Parkinson's Disease (PD)
What is being tested?
Novel neural recorder
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
1 Jul 2022to 2 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Has unilateral STN or GPi DBS and is approved to undergo second or contralateral side implantation;
  • Diagnosis of idiopathic PD;
  • A history of a good response to levodopa (carbidopa/levodopa) defined as at least a 30% improvement in motor unified Parkinson's disease rating scale (UPDRS) score;
  • DBS surgery at UMN is planned as part of routine clinical care.

Who cannot join

  • Other significant neurological disorder
  • History of dementia
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Evaluating and Understanding the Effects of Deep Brain Stimulation Using Novel Electrophysiology Technique and Device in Parkinson's Disease

The purpose of this research is to test a new recorder that can measure brain activity when stimulation is turned on during deep brain stimulation (DBS) surgery. To continue to improve DBS therapy, the investigators need to better understand the changes in the brain of people with Parkinson's disease (PD). They also need to know how this is affected by DBS. Current recorders measure activity immediately after, but not during, stimulation. Standard-of-care DBS already includes the electrical recording of brain activity during movement of arms and legs. These recordings occur during the microelectrode recording part of the surgery and are used by the medical team to determine where to place the DBS electrode.

Read the detailed description

Deep brain stimulation (DBS) is shown to be very effective in alleviating the motor symptoms of Parkinson's disease (PD). However, its exact mechanism is not well-understood. Clinical studies have reported conflicting results regarding the effects of DBS, with some studies suggesting that it inhibits target neurons while some others suggest that it excites those neurons. One of the significant hurdles plaguing the study of DBS is the large artifacts caused by electrical stimulation. The large artifacts saturate the neural recorder and also make it take a long time to recover to its normal working conditions. Consequently, no reliable neural feedback can be recorded during the high frequency stimulation of DBS. The investigators have developed a new neural recorder that does not saturate even in the presence of large artifacts. The recorder has been validated in animal studies and recently in human experiments. The investigators propose to further develop the device to study the mechanisms of DBS: in Aim 1, they will develop an artifact-resilient neural recorder and related software suite to support intraoperative monitoring during DBS. In Aim 2, they will use the proposed device to carry out an intraoperative electrophysiological recording of the subthalamic nucleus (STN) or globus pallidus internus (GPi) in PD patients. The investigators will compare activities of the neurons when high or low stimulation frequency is used, when stimulation is delivered ipsilaterally or contralaterally, and when different temporal patterns of DBS pulses are used. Measurements of therapeutic effects in terms of tremor power will be obtained by a wireless inertial measurement unit. The investigators will correlate tremor power, neural responses, and stimulation parameters during DBS, which can provide new insights into the mechanisms of DBS. These insights can potentially lead to a better stimulation paradigm that can enhance the efficacy of DBS.

Being tested
Novel neural recorder
Keywords
DBS, Deep brain stimulation, Parkinson's disease, PD
Medical subject headings
Parkinson Disease

What participants receive

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

  • Novel neural recorderDevice

    The neural recorder does not suffer saturation from stimulation artifacts, allowing circuits to record neural signals with higher precision.

Study groups in NCT07213999
Study groupRoleWhat they receive
Neural recorderExperimentalNot described
Receives: Device: Novel neural recorder

What is being measured

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

  1. Wireless 9-axis inertial measurement unit (IMU) with 3-axis accelerometer, gyroscope, and magnetometer will quantitatively measure the activity of neurons when high or low stimulation frequency is used.

    The investigators will compare the activity of neurons when high or low stimulation frequency is used, when stimulation is delivered ipsilaterally or contralaterally, and when different temporal patterns of DBS pulses are used within the constraints of standard clinical practice.

    Measured: For the duration of the participant's' DBS surgery.

Timeline

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

  1. First posted9 Oct 2025
  2. Study start1 Jul 2022
  3. Primary completion2 Jul 2022
  4. Study completion2 Jul 2022

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07213999
Sponsor's protocol ID
STUDY00005478
Other IDs
R21NS111214-01
Status last verified
Oct 2025
First submitted
29 Sep 2025
Last updated
9 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tabbal SD, Ushe M, Mink JW, Revilla FJ, Wernle AR, Hong M, Karimi M, Perlmutter JS. Unilateral subthalamic nucleus stimulation has a measurable ipsilateral effect on rigidity and bradykinesia in Parkinson disease. Exp Neurol. 2008 May;211(1):234-42. doi: 10.1016/j.expneurol.2008.01.024. Epub 2008 Feb 14.

    PubMed 18329019

  • Nakamura K, Christine CW, Starr PA, Marks WJ Jr. Effects of unilateral subthalamic and pallidal deep brain stimulation on fine motor functions in Parkinson's disease. Mov Disord. 2007 Apr 15;22(5):619-26. doi: 10.1002/mds.21300.

    PubMed 17230483

  • Alberts JL, Okun MS, Vitek JL. The persistent effects of unilateral pallidal and subthalamic deep brain stimulation on force control in advanced Parkinson's patients. Parkinsonism Relat Disord. 2008 Aug;14(6):481-8. doi: 10.1016/j.parkreldis.2007.11.014. Epub 2008 Mar 14.

    PubMed 18342565

  • Pogosyan A, Yoshida F, Chen CC, Martinez-Torres I, Foltynie T, Limousin P, Zrinzo L, Hariz MI, Brown P. Parkinsonian impairment correlates with spatially extensive subthalamic oscillatory synchronization. Neuroscience. 2010 Nov 24;171(1):245-57. doi: 10.1016/j.neuroscience.2010.08.068. Epub 2010 Sep 9.

    PubMed 20832452

  • A Low-Noise, Wireless, Frequency-Shaping based Neural Recorder

  • Zhi Yang, Jian Xu, Anh Tuan Nguyen, Tong Wu, Wenfeng Zhao, Wing-Kin Tam. Neuronix enables continuous, simultaneous neural recording and electrical microstimulation. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:4451-4454. doi: 10.1109/EMBC.2016.7591715.

    PubMed 28269266

  • Sharpee TO, Destexhe A, Kawato M, Sekulic V, Skinner FK, Wojcik DK, Chintaluri C, Cserpan D, Somogyvari Z, Kim JK, Kilpatrick ZP, Bennett MR, Josic K, Elices I, Arroyo D, Levi R, Rodriguez FB, Varona P, Hwang E, Kim B, Han HB, Kim T, McKenna JT, Brown RE, McCarley RW, Choi JH, Rankin J, Popp PO, Rinzel J, Tabas A, Rupp A, Balaguer-Ballester E, Maturana MI, Grayden DB, Cloherty SL, Kameneva T, Ibbotson MR, Meffin H, Koren V, Lochmann T, Dragoi V, Obermayer K, Psarrou M, Schilstra M, Davey N, Torben-Nielsen B, Steuber V, Ju H, Yu J, Hines ML, Chen L, Yu Y, Kim J, Leahy W, Shlizerman E, Birgiolas J, Gerkin RC, Crook SM, Viriyopase A, Memmesheimer RM, Gielen S, Dabaghian Y, DeVito J, Perotti L, Kim AJ, Fenk LM, Cheng C, Maimon G, Zhao C, Widmer Y, Sprecher S, Senn W, Halnes G, Maki-Marttunen T, Keller D, Pettersen KH, Andreassen OA, Einevoll GT, Yamada Y, Steyn-Ross ML, Alistair Steyn-Ross D, Mejias JF, Murray JD, Kennedy H, Wang XJ, Kruscha A, Grewe J, Benda J, Lindner B, Badel L, Ohta K, Tsuchimoto Y, Kazama H, Kahng B, Tam ND, Pollonini L, Zouridakis G, Soh J, Kim D, Yoo M, Palmer SE, Culmone V, Bojak I, Ferrario A, Merrison-Hort R, Borisyuk R, Kim CS, Tezuka T, Joo P, Rho YA, Burton SD, Bard Ermentrout G, Jeong J, Urban NN, Marsalek P, Kim HH, Moon SH, Lee DW, Lee SB, Lee JY, Molkov YI, Hamade K, Teka W, Barnett WH, Kim T, Markin S, Rybak IA, Forro C, Dermutz H, Demko L, Voros J, Babichev A, Huang H, Verduzco-Flores S, Dos Santos F, Andras P, Metzner C, Schweikard A, Zurowski B, Roach JP, Sander LM, Zochowski MR, Skilling QM, Ognjanovski N, Aton SJ, Zochowski M, Wang SJ, Ouyang G, Guang J, Zhang M, Michael Wong KY, Zhou C, Robinson PA, Sanz-Leon P, Drysdale PM, Fung F, Abeysuriya RG, Rennie CJ, Zhao X, Choe Y, Yang HF, Mi Y, Lin X, Wu S, Liedtke J, Schottdorf M, Wolf F, Yamamura Y, Wickens JR, Rumbell T, Ramsey J, Reyes A, Draguljic D, Hof PR, Luebke J, Weaver CM, He H, Yang X, Ma H, Xu Z, Wang Y, Baek K, Morris LS, Kundu P, Voon V, Agnes EJ, Vogels TP, Podlaski WF, Giese M, Kuravi P, Vogels R, Seeholzer A, Podlaski W, Ranjan R, Vogels T, Torres JJ, Baroni F, Latorre R, Gips B, Lowet E, Roberts MJ, de Weerd P, Jensen O, van der Eerden J, Goodarzinick A, Niry MD, Valizadeh A, Pariz A, Parsi SS, Warburton JM, Marucci L, Tamagnini F, Brown J, Tsaneva-Atanasova K, Kleberg FI, Triesch J, Moezzi B, Iannella N, Schaworonkow N, Plogmacher L, Goldsworthy MR, Hordacre B, McDonnell MD, Ridding MC, Zapotocky M, Smit D, Fouquet C, Trembleau A, Dasgupta S, Nishikawa I, Aihara K, Toyoizumi T, Robb DT, Mellen N, Toporikova N, Tang R, Tang YY, Liang G, Kiser SA, Howard JH Jr, Goncharenko J, Voronenko SO, Ahamed T, Stephens G, Yger P, Lefebvre B, Spampinato GLB, Esposito E, et Olivier Marre MS, Choi H, Song MH, Chung S, Lee DD, Sompolinsky H, Phillips RS, Smith J, Chatzikalymniou AP, Ferguson K, Alex Cayco Gajic N, Clopath C, Angus Silver R, Gleeson P, Marin B, Sadeh S, Quintana A, Cantarelli M, Dura-Bernal S, Lytton WW, Davison A, Li L, Zhang W, Wang D, Song Y, Park S, Choi I, Shin HS, Choi H, Pasupathy A, Shea-Brown E, Huh D, Sejnowski TJ, Vogt SM, Kumar A, Schmidt R, Van Wert S, Schiff SJ, Veale R, Scheutz M, Lee SW, Gallinaro J, Rotter S, Rubchinsky LL, Cheung CC, Ratnadurai-Giridharan S, Shomali SR, Ahmadabadi MN, Shimazaki H, Nader Rasuli S, Zhao X, Rasch MJ, Wilting J, Priesemann V, Levina A, Rudelt L, Lizier JT, Spinney RE, Rubinov M, Wibral M, Bak JH, Pillow J, Zaho Y, Park IM, Kang J, Park HJ, Jang J, Paik SB, Choi W, Lee C, Song M, Lee H, Park Y, Yilmaz E, Baysal V, Ozer M, Saska D, Nowotny T, Chan HK, Diamond A, Herrmann CS, Murray MM, Ionta S, Hutt A, Lefebvre J, Weidel P, Duarte R, Morrison A, Lee JH, Iyer R, Mihalas S, Koch C, Petrovici MA, Leng L, Breitwieser O, Stockel D, Bytschok I, Martel R, Bill J, Schemmel J, Meier K, Esler TB, Burkitt AN, Kerr RR, Tahayori B, Nolte M, Reimann MW, Muller E, Markram H, Parziale A, Senatore R, Marcelli A, Skiker K, Maouene M, Neymotin SA, Seidenstein A, Lakatos P, Sanger TD, Menzies RJ, McLauchlan C, van Albada SJ, Kedziora DJ, Neymotin S, Kerr CC, Suter BA, Shepherd GMG, Ryu J, Lee SH, Lee J, Lee HJ, Lim D, Wang J, Lee H, Jung N, Anh Quang L, Maeng SE, Lee TH, Lee JW, Park CH, Ahn S, Moon J, Choi YS, Kim J, Jun SB, Lee S, Lee HW, Jo S, Jun E, Yu S, Goetze F, Lai PY, Kim S, Kwag J, Jang HJ, Filipovic M, Reig R, Aertsen A, Silberberg G, Bachmann C, Buttler S, Jacobs H, Dillen K, Fink GR, Kukolja J, Kepple D, Giaffar H, Rinberg D, Shea S, Koulakov A, Bahuguna J, Tetzlaff T, Kotaleski JH, Kunze T, Peterson A, Knosche T, Kim M, Kim H, Park JS, Yeon JW, Kim SP, Kang JH, Lee C, Spiegler A, Petkoski S, Palva MJ, Jirsa VK, Saggio ML, Siep SF, Stacey WC, Bernar C, Choung OH, Jeong Y, Lee YI, Kim SH, Jeong M, Lee J, Kwon J, Kralik JD, Jahng J, Hwang DU, Kwon JH, Park SM, Kim S, Kim H, Kim PS, Yoon S, Lim S, Park C, Miller T, Clements K, Ahn S, Ji EH, Issa FA, Baek J, Oba S, Yoshimoto J, Doya K, Ishii S, Mosqueiro TS, Strube-Bloss MF, Smith B, Huerta R, Hadrava M, Hlinka J, Bos H, Helias M, Welzig CM, Harper ZJ, Kim WS, Shin IS, Baek HM, Han SK, Richter R, Vitay J, Beuth F, Hamker FH, Toppin K, Guo Y, Graham BP, Kale PJ, Gollo LL, Stern M, Abbott LF, Fedorov LA, Giese MA, Ardestani MH, Faraji MJ, Preuschoff K, Gerstner W, van Gendt MJ, Briaire JJ, Kalkman RK, Frijns JHM, Lee WH, Frangou S, Fulcher BD, Tran PHP, Fornito A, Gliske SV, Lim E, Holman KA, Fink CG, Kim JS, Mu S, Briggman KL, Sebastian Seung H; the EyeWirers; Wegener D, Bohnenkamp L, Ernst UA, Devor A, Dale AM, Lines GT, Edwards A, Tveito A, Hagen E, Senk J, Diesmann M, Schmidt M, Bakker R, Shen K, Bezgin G, Hilgetag CC, van Albada SJ, Sun H, Sourina O, Huang GB, Klanner F, Denk C, Glomb K, Ponce-Alvarez A, Gilson M, Ritter P, Deco G, Witek MAG, Clarke EF, Hansen M, Wallentin M, Kringelbach ML, Vuust P, Klingbeil G, De Schutter E, Chen W, Zang Y, Hong S, Takashima A, Zamora C, Gallimore AR, Goldschmidt D, Manoonpong P, Karoly PJ, Freestone DR, Soundry D, Kuhlmann L, Paninski L, Cook M, Lee J, Fishman YI, Cohen YE, Roberts JA, Cocchi L, Sweeney Y, Lee S, Jung WS, Kim Y, Jung Y, Song YK, Chavane F, Soman K, Muralidharan V, Srinivasa Chakravarthy V, Shivkumar S, Mandali A, Pragathi Priyadharsini B, Mehta H, Davey CE, Brinkman BAW, Kekona T, Rieke F, Buice M, De Pitta M, Berry H, Brunel N, Breakspear M, Marsat G, Drew J, Chapman PD, Daly KC, Bradle SP, Seo SB, Su J, Kavalali ET, Blackwell J, Shiau L, Buhry L, Basnayake K, Lee SH, Levy BA, Baker CI, Leleu T, Philips RT, Chhabria K. 25th Annual Computational Neuroscience Meeting: CNS-2016. BMC Neurosci. 2016 Aug 18;17 Suppl 1(Suppl 1):54. doi: 10.1186/s12868-016-0283-6.

    PubMed 27534393

  • Xu J, Wu T, Liu W, Yang Z. A frequency shaping neural recorder with 3 pF input capacitance and 11 plus 4.5 bits dynamic range. IEEE Trans Biomed Circuits Syst. 2014 Aug;8(4):510-27. doi: 10.1109/TBCAS.2013.2293821.

    PubMed 25073127

  • Baker KB, Zhang J, Vitek JL. Pallidal stimulation: effect of pattern and rate on bradykinesia in the non-human primate model of Parkinson's disease. Exp Neurol. 2011 Oct;231(2):309-13. doi: 10.1016/j.expneurol.2011.06.012. Epub 2011 Jul 1.

    PubMed 21767534

  • Birdno MJ, Kuncel AM, Dorval AD, Turner DA, Grill WM. Tremor varies as a function of the temporal regularity of deep brain stimulation. Neuroreport. 2008 Mar 26;19(5):599-602. doi: 10.1097/WNR.0b013e3282f9e45e.

    PubMed 18388746

  • Dorval AD, Kuncel AM, Birdno MJ, Turner DA, Grill WM. Deep brain stimulation alleviates parkinsonian bradykinesia by regularizing pallidal activity. J Neurophysiol. 2010 Aug;104(2):911-21. doi: 10.1152/jn.00103.2010. Epub 2010 May 26.

    PubMed 20505125

  • Johnson LA, Nebeck SD, Muralidharan A, Johnson MD, Baker KB, Vitek JL. Closed-Loop Deep Brain Stimulation Effects on Parkinsonian Motor Symptoms in a Non-Human Primate - Is Beta Enough? Brain Stimul. 2016 Nov-Dec;9(6):892-896. doi: 10.1016/j.brs.2016.06.051. Epub 2016 Jun 22.

    PubMed 27401045

  • Hess CW, Vaillancourt DE, Okun MS. The temporal pattern of stimulation may be important to the mechanism of deep brain stimulation. Exp Neurol. 2013 Sep;247:296-302. doi: 10.1016/j.expneurol.2013.02.001. Epub 2013 Feb 8.

    PubMed 23399890

  • 15-DOF motor decoding based on a high performance PNS interface and deep neural network

  • Galati S, Mazzone P, Fedele E, Pisani A, Peppe A, Pierantozzi M, Brusa L, Tropepi D, Moschella V, Raiteri M, Stanzione P, Bernardi G, Stefani A. Biochemical and electrophysiological changes of substantia nigra pars reticulata driven by subthalamic stimulation in patients with Parkinson's disease. Eur J Neurosci. 2006 Jun;23(11):2923-8. doi: 10.1111/j.1460-9568.2006.04816.x.

    PubMed 16819981

Questions about this trial

What is this clinical trial studying?

A study testing Novel neural recorder in people with Parkinson's Disease (PD), run by University of Minnesota 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 9 Oct 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Wireless 9-axis inertial measurement unit (IMU) with 3-axis accelerometer, gyroscope, and magnetometer will quantitatively measure the activity of neurons when high or low stimulation frequency is used. (time frame: For the duration of the participant's' DBS surgery.). 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 NCT07213999, which also lists 21 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 9 Oct 2025.

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