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

Official title

Chronic Stimulation of the Motor Ventral Thalamus (VOP/VIM) for Motor Control in Humans

Overview

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

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.

Interventions

• Device 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.

Primary outcome measures

• Upper Limb Motor Function - Hand Dexterity [Time frame: 2 years]
• Upper Limb Motor Function - Grip Strength [Time frame: 2 years]
• Upper Limb Motor Function - Velocity [Time frame: 2 years]
• Upper Limb Motor Function - Strength Modulation [Time frame: 2 years]
• Facial Muscle Motor Function [Time frame: 2 years]
• Swallowing Function [Time frame: 2 years]
• Speech Intelligibility [Time frame: 2 years]
• Dexterity of Articulation AMRs [Time frame: 2 years]
• Dexterity of Articulation SMRs [Time frame: 2 years]
• Oral Motor Functions [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Pittsburgh — Pittsburgh

Publications

• 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. PMID 18334861
• 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. PMID 10963204
• 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. PMID 6975064
• 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: 10.1 PMID 37580534
• 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. PMID 15955943
• Plow EB, Machado A. Invasive neurostimulation in stroke rehabilitation. Neurotherapeutics. 2014 Jul;11(3):572-82. doi: 10.1007/s13311-013-0245-y. PMID 24353109
• 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. PMID 30683913
• 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. PMID 39353911

Identifiers

NCT: NCT07056348 · STUDY21100020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗