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CompletedNCT03320681Updated May 24, 2018

Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

An interventional study of Electrical Stimulation and Dry Needling Stimulation in Parkinson Disease, sponsored by Inventram. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-24.

Sponsored by Inventram · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms

Read the detailed description

Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Neurostimulator
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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-
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    Active Stimulation

    Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes.

    Device: Electrical Stimulation

  • Other
    Dry Needling

    Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given

    Other: Dry Needling Stimulation

Interventions

  • DeviceElectrical Stimulation

    Percutaneous electrical nerve stimulation

  • OtherDry Needling Stimulation

    Percutaneous nerve stimulation

05

What researchers measure

Primary outcomes

  1. fMRI - Activation level comparison of the motor and supplementary cortex

    Time frame: Baseline and PostStim (right after the stimulation is terminated)

  2. fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)

    Time frame: Baseline and PostStim (right after the stimulation is terminated)

  3. fMRI - STN, PPN and cortical connectivity alterations

    Time frame: Baseline and PostStim (right after the stimulation is terminated)

06

Study locations

1 site
  • Koc University Hospital
    İstanbul, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03320681
Lead sponsor
Inventram
Collaborators
Koç University
Responsible party
Sponsor
First posted
Oct 25, 2017
Start date
May 20, 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
May 24, 2018

Study contacts

Yusuf O Cakmak, Phd, MD
principal investigator · Otago University
Burak Ozsoy, PhD
study director · Inventram

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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