NCT02722824

Brief Summary

Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

March 6, 2016

Last Update Submit

July 24, 2017

Conditions

Parkinson's Disease

Keywords

motor symptoms

Outcome Measures

Primary Outcomes (2)

  • Change in the UPDRS Motor Score (Part III)

    Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation

    10 minutes after the stimulation is initiated.

  • Change in the UPDRS Motor Score (Part III)

    Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.

    30 minutes after the stimulation is terminated.

Secondary Outcomes (28)

  • Change in the gait and balance parameters (cadence)

    10 minutes after the stimulation is initiated.

  • Change in the gait and balance parameters (Stride length)

    10 minutes after the stimulation is initiated.

  • Change in the gait and balance parameters (Stride velocity)

    10 minutes after the stimulation is initiated.

  • Change in the gait and balance parameters

    10 minutes after the stimulation is initiated.

  • Change in the gait and balance parameters

    10 minutes after the stimulation is initiated.

  • +23 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes

Other: Placebo

Active Stimulation

EXPERIMENTAL

Instrinsic auricular muscles will be stimulated for 20 minutes

Device: Electro-stimulation

Sham

SHAM COMPARATOR

An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes

Device: Electro-stimulation

Passive Control

NO INTERVENTION

Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes

Interventions

Electro-stimulationDEVICE
Active StimulationSham
PlaceboOTHER
Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Parkinson's Disease
  • H\&Y Stage \>= 2
  • Existing bradykinesia symptoms
  • Existence of one of the symptoms below
  • Resting Tremor
  • Rigidity
  • Walking disorder

You may not qualify if:

  • Cardiac Pacemaker
  • Psychiatric diagnosis
  • Irregular heart/respiration rate
  • Pregnancy
  • Alcohol consumption
  • Cardiovascular disease history
  • Wearing an electro-active prosthesis
  • Brain surgery history
  • Ongoing TENS/PENS therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Koc University Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

First Submitted

March 6, 2016

First Posted

March 30, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

TU(2)