NCT01945567

Brief Summary

The posterior subthalamic area holds promise as a target region for deep brain stimulation in tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide tube surgical technique, subregions of the posterior subthalamic area can be individually targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona incerta may provide improved control of movement disorder symptoms than the more commonly stimulated dorsal zona incerta.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

7.1 years

First QC Date

September 14, 2013

Last Update Submit

May 13, 2021

Conditions

Parkinson's DiseaseTremor

Keywords

Parkinson's diseaseEssential tremorTremorDeep brain stimulationPosterior subthalamic areaZona incerta

Outcome Measures

Primary Outcomes (6)

  • Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months

    At end of first randomised crossover trial period

    3 months

  • Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months

    At end of second randomised crossover trial period

    6 months

  • Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months

    At end of non-randomised empirical deep brain stimulator programming period

    12 months

  • Change from baseline Fahn Tolosa Marin tremor scale at 3 months

    At end of first randomised crossover trial period for tremor patients

    3 months

  • Change from baseline Fahn Tolosa Marin tremor scale at 6 months

    At end of second randomised crossover trial period for tremor patients

    6 months

  • Change from baseline Fahn Tolosa Marin tremor scale at 12 months

    At end of empirical deep brain stimulator programming period for tremor patients

    12 months

Secondary Outcomes (28)

  • Change from baseline ON-OFF diary at 3 months

    3 months

  • Change from baseline ON-OFF diary at 6 months

    6 months

  • Change from baseline ON-OFF diary at 12 months

    12 months

  • Adverse events

    12 months

  • Change from baseline Short form 36 at 3 months

    3 months

  • +23 more secondary outcomes

Study Arms (3)

Dorsal zona incerta

EXPERIMENTAL

Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Caudal zona incerta

EXPERIMENTAL

Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Empirical deep brain stimulation

EXPERIMENTAL

Empirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome.

Device: Empirical unblinded deep brain stimulation programming

Interventions

Up to 3 mA, 60 us, 130 Hz deep brain stimulationDEVICE
Caudal zona incertaDorsal zona incerta
Empirical unblinded deep brain stimulation programmingDEVICE
Empirical deep brain stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medication-refractory tremor and/or Parkinson's disease as defined by UK Brain Bank criteria with either inadequate control of motor fluctuations or dyskinesia despite optimised medical therapy

You may not qualify if:

  • Significant cognitive, psychiatric and medical co-morbidities
  • Dementia with mini mental state examination score of less than 25/30
  • Limited life expectancy due to a co-morbid condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Parkinson DiseaseTremorEssential Tremor

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Lind, MBChB, FRACS

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Surgery

Study Record Dates

First Submitted

September 14, 2013

First Posted

September 18, 2013

Study Start

August 1, 2012

Primary Completion

August 30, 2019

Study Completion

August 30, 2020

Last Updated

May 18, 2021

Record last verified: 2021-05

Locations

AU(1)