Expanding the Therapeutic Window of Deep Brain Stimulation in Parkinson's Disease by Means of Directional Leads

NCT04093544 | Unknown DMC

• 1 other identifier: 17-5705
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring directional lead

Conditions

Parkinson Disease

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Number/incidence of adverse events

  Number/incidence of adverse events

  Throughout the study, averaging 6 months

Secondary Outcomes (15)

• Change from baseline in a measure of health related quality of life and non-motor symptoms of Parkinson's disease using the Parkinson's disease Questionnaire (PDQ-39)

  After 3 months of each intervention

• Patients Global Impression of Change (PGIC)

  After 3 months of each intervention

• Change in articulation rate of speech using a Phonetics Software

  After 3 months of each intervention

• Change in dysfluency of speech using a Phonetics Software

  After 3 months of each intervention

• Change in intelligibility of speech using a Phonetics Software

  After 3 months of each intervention

Study Arms (2)

Standard Stimulation

ACTIVE COMPARATOR

Participants will receive stimulation using the best contact combination in ring mode.

Device: Deep brain stimulation

Directional Stimulation

EXPERIMENTAL

Participants will receive stimulation using the best segmented (steered) contacts.

Device: Deep brain stimulation

Interventions

Deep brain stimulation DEVICE

Steered stimulation using directional leads

Directional Stimulation; Standard Stimulation

Eligibility Criteria

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

You may not qualify if:

• Male and female patients with idiopathic PD, who have symptoms responsive to L- dopa medications, but who have significant impairment related to PD that is no longer well controlled with pharmacotherapy (i.e., refractory to optimized medical therapy)
• Patients considered as subthalamic nucleus deep brain stimulation (STN-DBS) candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
• Patients aged 18 to 80 years.
• Quality of life and social functioning influenced by levodopa-responsive symptoms 6) No major comorbidities

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Movement disorders Centre, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (7)

• Fasano A, Daniele A, Albanese A. Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Lancet Neurol. 2012 May;11(5):429-42. doi: 10.1016/S1474-4422(12)70049-2.

  PMID: 22516078 BACKGROUND

• Herzog J, Pinsker M, Wasner M, Steigerwald F, Wailke S, Deuschl G, Volkmann J. Stimulation of subthalamic fibre tracts reduces dyskinesias in STN-DBS. Mov Disord. 2007 Apr 15;22(5):679-84. doi: 10.1002/mds.21387.

  PMID: 17266046 BACKGROUND

• Barbe MT, Maarouf M, Alesch F, Timmermann L. Multiple source current steering--a novel deep brain stimulation concept for customized programming in a Parkinson's disease patient. Parkinsonism Relat Disord. 2014 Apr;20(4):471-3. doi: 10.1016/j.parkreldis.2013.07.021. Epub 2013 Sep 14. No abstract available.

  PMID: 24041939 BACKGROUND

• Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.

  PMID: 26027940 BACKGROUND

• Contarino MF, Bour LJ, Verhagen R, Lourens MA, de Bie RM, van den Munckhof P, Schuurman PR. Directional steering: A novel approach to deep brain stimulation. Neurology. 2014 Sep 23;83(13):1163-9. doi: 10.1212/WNL.0000000000000823. Epub 2014 Aug 22.

  PMID: 25150285 BACKGROUND

• Steigerwald F, Muller L, Johannes S, Matthies C, Volkmann J. Directional deep brain stimulation of the subthalamic nucleus: A pilot study using a novel neurostimulation device. Mov Disord. 2016 Aug;31(8):1240-3. doi: 10.1002/mds.26669. Epub 2016 May 31.

  PMID: 27241197 BACKGROUND

• Pollo C, Kaelin-Lang A, Oertel MF, Stieglitz L, Taub E, Fuhr P, Lozano AM, Raabe A, Schupbach M. Directional deep brain stimulation: an intraoperative double-blind pilot study. Brain. 2014 Jul;137(Pt 7):2015-26. doi: 10.1093/brain/awu102. Epub 2014 May 19.

  PMID: 24844728 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Alfonso Fasano, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 7, 2019
• First Posted: September 18, 2019
• Study Start: May 15, 2018
• Primary Completion: May 15, 2020
• Study Completion: December 31, 2020
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)