Study on Feasibility of Targeted Epidural Spinal Stimulation (TESS) to Improve Mobility in Patients With Parkinson's Disease

NCT04956770 | Unknown DMC

• 1 other identifier: STIMO-PARK2021
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the STIMO-PARKINSON study is to evaluate the safety and preliminary efficacy of Targeted Epidural Spinal Stimulation (TESS) system to induce modulation in leg muscle recruitment in patients with advanced Parkinson's disease, and its capacity to improve key gait and balance deficits when employed in the context of a rehabilitation process of 3 to 5 months.

Conditions

Parkinson Disease

Keywords

Spinal Cord Stimulation System; DBS

Outcome Measures

Primary Outcomes (1)

• Occurence of all SAEs and AEs deemed or related to study procedure or to the study investigational system

  Evaluate the safety of TESS at supporting locomotor rehabilitation in patients with Parkinson's Disease

  Through study completion, an average of 6 months

Secondary Outcomes (9)

• EMG measurements of muscle recruitment in response to stimulation of increasing amplitudes for different contact configurations

  At baseline and during the 5-month TESS-supported rehabilitation phase

• Maximum voluntary contraction (MVC) of single joints

  At baseline and during the 5-month TESS-supported rehabilitation phase

• Muscle Fatigue Test

  At baseline and during the 5-month TESS-supported rehabilitation phase

• 10-meter walk test

  At baseline and during the 5-month TESS-supported rehabilitation phase

• 6 minute walk test

  At baseline and during the 5-month TESS-supported rehabilitation phase

Other Outcomes (6)

• Cortical (EEG) and subcortical signals (LFP from the subthalamic nucleus)

  At baseline and during the 5-month TESS-supported rehabilitation phase

• Quality of life questionnaire PDQ-39

  At baseline and during the 5-month TESS-supported rehabilitation phase

• Quality of life questionnaire ABC-Q

  At baseline and during the 5-month TESS-supported rehabilitation phase

Study Arms (1)

Rehabilitation supported by TESS

EXPERIMENTAL

Patient will be asked to come to the hospital for three types of patient sessions: * Stimulation configuration sessions: TESS protocols will be setup and optimized during this phase. Duration: minimum 4 sessions over 2 weeks, maximum 20 sessions over a month. In addition, some sessions at a free frequency as needed during rehabilitation will be programed (maximum once a week). * TESS-supported rehabilitation sessions: Patients will undergo an in-clinic rehabilitation training regime supported by TESS. Duration: 24 sessions spread over minimum three months and maximum five months * Pre- and post-rehabilitation evaluation sessions: four clinical evaluation sessions will take place focusing on assessment of locomotion, balance and PD related deficits.

Procedure: Implantation surgery

Interventions

Implantation surgery PROCEDURE

The intervention involves the implantation of: * a neurostimulator: the Activa® RC from Medtronic * a stimulation electrode paddle array: the Specify™ SureScan® 5-6-5 from Medtronic

Rehabilitation supported by TESS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic Parkinson's disease with III-IV Hoehn-Yahr stage, exhibiting severe gait difficulties and postural instability
• With Medtronic DBS implant and receiving medication for Parkinson's disease
• Aged 18 to 80 years
• Stable medical, physical and psychological condition as considered by the Investigators in accordance with treating physician and treating neurologist.
• Must agree to comply in good faith with all conditions of the study and to attend all required study training and visit
• Must provide and sign the study's Informed Consent prior to any study-related procedures

You may not qualify if:

• Severe or chronic medical disorder pre-existing PD diagnosis affecting rehabilitation
• Active oncological disease requiring heavy treatments and frequent MRI controls
• Having an implanted device that is active (e.g., pacemaker, implantable cardiac defibrillator) whose interference with the investigational system's neurostimulator (Activa RC) is not confirmed safe by the CE-mark of the device, or having an indication that might lead to implantation of such device
• Inability to follow study procedures, e.g. due to language problems, psychological disorders, dementia as considered by the Investigators in accordance with treating physician and treating neurologist
• Hematological disorders with an increased risk of hemorrhagic event during surgical interventions
• Life expectancy of less than 12 months
• Pregnant or breast feeding
• Participation in another interventional study

Sponsors & Collaborators

• Jocelyne Bloch: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (10)

• Strauss I, Kalia SK, Lozano AM. Where are we with surgical therapies for Parkinson's disease? Parkinsonism Relat Disord. 2014 Jan;20 Suppl 1:S187-91. doi: 10.1016/S1353-8020(13)70044-0.

  PMID: 24262178 BACKGROUND

• Courtine G, Bloch J. Defining ecological strategies in neuroprosthetics. Neuron. 2015 Apr 8;86(1):29-33. doi: 10.1016/j.neuron.2015.02.039.

  PMID: 25856483 BACKGROUND

• Courtine G, Gerasimenko Y, van den Brand R, Yew A, Musienko P, Zhong H, Song B, Ao Y, Ichiyama RM, Lavrov I, Roy RR, Sofroniew MV, Edgerton VR. Transformation of nonfunctional spinal circuits into functional states after the loss of brain input. Nat Neurosci. 2009 Oct;12(10):1333-42. doi: 10.1038/nn.2401. Epub 2009 Sep 20.

  PMID: 19767747 BACKGROUND

• Capogrosso M, Milekovic T, Borton D, Wagner F, Moraud EM, Mignardot JB, Buse N, Gandar J, Barraud Q, Xing D, Rey E, Duis S, Jianzhong Y, Ko WK, Li Q, Detemple P, Denison T, Micera S, Bezard E, Bloch J, Courtine G. A brain-spine interface alleviating gait deficits after spinal cord injury in primates. Nature. 2016 Nov 10;539(7628):284-288. doi: 10.1038/nature20118.

  PMID: 27830790 BACKGROUND

• Fuentes R, Petersson P, Siesser WB, Caron MG, Nicolelis MA. Spinal cord stimulation restores locomotion in animal models of Parkinson's disease. Science. 2009 Mar 20;323(5921):1578-82. doi: 10.1126/science.1164901.

  PMID: 19299613 BACKGROUND

• Yadav AP, Nicolelis MAL. Electrical stimulation of the dorsal columns of the spinal cord for Parkinson's disease. Mov Disord. 2017 Jun;32(6):820-832. doi: 10.1002/mds.27033. Epub 2017 May 12.

  PMID: 28497877 BACKGROUND

• Santana MB, Halje P, Simplicio H, Richter U, Freire MAM, Petersson P, Fuentes R, Nicolelis MAL. Spinal cord stimulation alleviates motor deficits in a primate model of Parkinson disease. Neuron. 2014 Nov 19;84(4):716-722. doi: 10.1016/j.neuron.2014.08.061. Epub 2014 Oct 30.

  PMID: 25447740 BACKGROUND

• Cai Y, Reddy RD, Varshney V, Chakravarthy KV. Spinal cord stimulation in Parkinson's disease: a review of the preclinical and clinical data and future prospects. Bioelectron Med. 2020 Mar 16;6:5. doi: 10.1186/s42234-020-00041-9. eCollection 2020.

  PMID: 32232113 BACKGROUND

• Prasad S, Aguirre-Padilla DH, Poon YY, Kalsi-Ryan S, Lozano AM, Fasano A. Spinal Cord Stimulation for Very Advanced Parkinson's Disease: A 1-Year Prospective Trial. Mov Disord. 2020 Jun;35(6):1082-1083. doi: 10.1002/mds.28065. Epub 2020 Apr 20. No abstract available.

  PMID: 32311155 BACKGROUND

• Cury RG, Carra RB, Capato TTC, Teixeira MJ, Barbosa ER. Spinal Cord Stimulation for Parkinson's Disease: Dynamic Habituation as a Mechanism of Failure? Mov Disord. 2020 Oct;35(10):1882-1883. doi: 10.1002/mds.28271. No abstract available.

  PMID: 33068473 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jocelyne Bloch, MD

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Neurosurgeon

Model Details: Single center, non-randomized, interventional study

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: July 9, 2021
• Study Start: June 14, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)