NCT03417271

Brief Summary

The aim of this investigation is to explore the effect of reducing conventional pulse width of stimulation on known adverse effects of Subthalamic nucleus Deep Brain Stimulation (STN DBS) treatment such as; slurring of speech, gait impairment, and unsteadiness. This investigation is designed such that each of 16 patients (who have all had chronically implanted DBS systems), will be assessed using conventional (DBS-60µs) and short (DBS-30µs) pulse width DBS, in a randomised order.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

January 17, 2018

Last Update Submit

April 16, 2019

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Speech Intelligibility test

    Percentage of intelligible words spoken during formal speech assessment

    4 weeks

Secondary Outcomes (4)

  • Movement Disorders Society Unified Parkinson's Disease Rating Scale

    4 weeks

  • Dyskinesia Rating Scale

    4 weeks

  • Verbal Fluency

    4 weeks

  • Timed Motor tests

    4 weeks

Study Arms (2)

30us stimulation then 60us stimulation

ACTIVE COMPARATOR

All patients will receive both types of stimulation in a randomised crossover design. This arm will receive 30us stimulation for 4 weeks then will be switched to 60us stimulation for 4 weeks.

Device: Deep brain stimulation

60us stimulation then 30us stimulation

ACTIVE COMPARATOR

All patients will receive both types of stimulation in a randomised crossover design.This arm will receive 60us stimulation for 4 weeks then will be switched to 30us stimulation for 4 weeks.

Device: Deep brain stimulation

Interventions

Deep brain stimulationDEVICE

The different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer.

30us stimulation then 60us stimulation60us stimulation then 30us stimulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female.
  • Treatment with subthalamic deep brain stimulation using Medtronic Activa PC hardware for at least 12 months.
  • Experiencing stimulation-induced slurring of speech defined as scoring 50-80% speech intelligibility on the Assessment of Intelligibility of Speech scale.
  • All patients will be ≥ 25 and ≤ 75 years of age.
  • Documented informed consent to participate.

You may not qualify if:

  • Patients unable to provide documented informed consent.
  • Already actively participating in an investigation of a drug, device or surgical treatment for Parkinson's disease.
  • Potential participants who lack the capacity to give informed consent.
  • Any medical, psychiatric or other condition which in the investigator's opinion compromises the potential participant's ability to participate fully.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCL Institute of Neurology

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Thomas Foltynie, MRCP PhD

    UCL Institute of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Neither participants nor outcomes assessors will be aware whether the patient is receiving stimulation at 30us or 60us pulse widths.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 31, 2018

Study Start

May 2, 2018

Primary Completion

October 24, 2018

Study Completion

October 24, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)