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Long-term Brain Stimulation of the Motor Ventral Thalamus (VOP/VIM) to Improve Motor Function

NCT ID: NCT07056348

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2030-12-31

Brief Summary

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This study aims to recruit patients already implanted with Deep Brain Stimulation (DBS) for movement disorders to complete tasks assessing parameters of motor output, speech, and swallowing functions, both with and without stimulation. DBS parameters would be adjusted prior to motor testing. Patients would then participate in multiple sessions performing contralateral upper extremity movement tasks measuring movement speed, grip strength, and strength modulation, facial movement, swallowing, and speech tasks.

Detailed Description

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The study is designed to assess the assistive effects of DBS (i.e., immediate effects when the stimulation is turned ON) and obtain preliminary evidence for therapeutic effects (i.e., long-lasting effects with stimulation OFF). Researchers will 1) quantify the ability to recruit facial and oropharyngeal muscles with electrical stimulation of the motor thalamus in patients with DBS for movement disorders, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with DBS, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.

Conditions

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Traumatic Brain Injury Stroke Brain Disease Movement Disorders (Incl Parkinsonism) Central Nervous System Disease Essential Tremor, Movement Disorders Essential Tremor of Voice

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective, non-randomized, open-label, descriptive, experimental.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation of the Motor Thalamus

Individuals with deep brain stimulation device implanted in the motor thalamus for movement disorders treatment who also sustain speech, swallowing, and motor deficits.

Group Type EXPERIMENTAL

Deep Brain Stimulation (DBS) of the Motor Thalamus

Intervention Type DEVICE

All participants enrolled will undergo stimulation parameters tuning of deep brain stimulation electrode leads. All subjects will participate in a series of experiments to evaluate the stimulation effects on movement of face and upper extremities, swallowing, and speech abilities.

Healthy Control Participants

The investigators aim to include healthy control subjects who will complete the language and upper-limb tasks. The healthy subjects will not undergo any surgical procedures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deep Brain Stimulation (DBS) of the Motor Thalamus

All participants enrolled will undergo stimulation parameters tuning of deep brain stimulation electrode leads. All subjects will participate in a series of experiments to evaluate the stimulation effects on movement of face and upper extremities, swallowing, and speech abilities.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Movement disorder patients ≥18 years of age and \< 80 years of age, who will be implanted with DBS for treatment of motor symptoms.
* Subject has provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures.

Exclusion Criteria

* History of seizure disorders
* Vasovagal response history and loss of consciousness history
* Severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator would impact participation in the study.
* Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions other than current movement disorder) or cognitive impairments that could impair ability to participate in this study.
* Females who are pregnant or breastfeeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jorge Gonzalez-Martinez

OTHER

Sponsor Role lead

Responsible Party

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Jorge Gonzalez-Martinez

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jorge Gonzalez-Martinez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cierra Clark, MS

Role: CONTACT

Phone: 240-441-4216

Email: [email protected]

Elvira Pirondini, PhD

Role: CONTACT

Phone: 412-636-0595

Email: [email protected]

Facility Contacts

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Cierra Clark, MS

Role: primary

Elvira Pirondini, PhD

Role: backup

References

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Franzini A, Cordella R, Nazzi V, Broggi G. Long-term chronic stimulation of internal capsule in poststroke pain and spasticity. Case report, long-term results and review of the literature. Stereotact Funct Neurosurg. 2008;86(3):179-83. doi: 10.1159/000120431. Epub 2008 Mar 12.

Reference Type BACKGROUND
PMID: 18334861 (View on PubMed)

Phillips NI, Bhakta BB. Affect of deep brain stimulation on limb paresis after stroke. Lancet. 2000 Jul 15;356(9225):222-3. doi: 10.1016/s0140-6736(00)02487-9.

Reference Type BACKGROUND
PMID: 10963204 (View on PubMed)

Cooper IS, Upton AR, Amin I. Reversibility of chronic neurologic deficits. Some effects of electrical stimulation of the thalamus and internal capsule in man. Appl Neurophysiol. 1980;43(3-5):244-58. doi: 10.1159/000102263.

Reference Type BACKGROUND
PMID: 6975064 (View on PubMed)

Baker KB, Plow EB, Nagel S, Rosenfeldt AB, Gopalakrishnan R, Clark C, Wyant A, Schroedel M, Ozinga J 4th, Davidson S, Hogue O, Floden D, Chen J, Ford PJ, Sankary L, Huang X, Cunningham DA, DiFilippo FP, Hu B, Jones SE, Bethoux F, Wolf SL, Chae J, Machado AG. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nat Med. 2023 Sep;29(9):2366-2374. doi: 10.1038/s41591-023-02507-0. Epub 2023 Aug 14.

Reference Type BACKGROUND
PMID: 37580534 (View on PubMed)

Molnar GF, Sailer A, Gunraj CA, Cunic DI, Lang AE, Lozano AM, Moro E, Chen R. Changes in cortical excitability with thalamic deep brain stimulation. Neurology. 2005 Jun 14;64(11):1913-9. doi: 10.1212/01.WNL.0000163985.89444.DD.

Reference Type BACKGROUND
PMID: 15955943 (View on PubMed)

Plow EB, Machado A. Invasive neurostimulation in stroke rehabilitation. Neurotherapeutics. 2014 Jul;11(3):572-82. doi: 10.1007/s13311-013-0245-y.

Reference Type BACKGROUND
PMID: 24353109 (View on PubMed)

Lozano AM, Lipsman N, Bergman H, Brown P, Chabardes S, Chang JW, Matthews K, McIntyre CC, Schlaepfer TE, Schulder M, Temel Y, Volkmann J, Krauss JK. Deep brain stimulation: current challenges and future directions. Nat Rev Neurol. 2019 Mar;15(3):148-160. doi: 10.1038/s41582-018-0128-2.

Reference Type BACKGROUND
PMID: 30683913 (View on PubMed)

Ho JC, Grigsby EM, Damiani A, Liang L, Balaguer JM, Kallakuri S, Tang LW, Barrios-Martinez J, Karapetyan V, Fields D, Gerszten PC, Hitchens TK, Constantine T, Adams GM, Crammond DJ, Capogrosso M, Gonzalez-Martinez JA, Pirondini E. Potentiation of cortico-spinal output via targeted electrical stimulation of the motor thalamus. Nat Commun. 2024 Oct 1;15(1):8461. doi: 10.1038/s41467-024-52477-1.

Reference Type BACKGROUND
PMID: 39353911 (View on PubMed)

Other Identifiers

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STUDY21100020

Identifier Type: -

Identifier Source: org_study_id