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The Effects of Multi-focal tDCS on Motor-cognitive Dysfunctions in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02656316
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:
The current RCT aims to establish the therapeutic potential of tDCS for freezing of gait (FOG) and motor-cognitive dysfunctions in PD. As noted, FOG is often unresponsive to pharmacological and other treatments, especially in the advanced stages of the disease. While it is likely that tDCS will provide symptomatic relief, we will also explore, via secondary outcomes, the potential for tDCS to modify disease progression. Support for this possibility stems from the likely mechanisms of action of tDCS.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Active tDCS Device: Sham tDCS Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Multi-focal Transcranial Direct Current Stimulation (tDCS) on Motor-cognitive Dysfunctions and Freezing of Gait in Patients With Parkinson's Disease: A Randomized Controlled Trial
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
The active tDCS condition will consist of 20 min of continuous stimulation. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions.
Device: Active tDCS
In this group subjects will receive 20 min of treatment.

Sham Comparator: Sham tDCS
The Sham tDCS - an inactive stimulation.
Device: Sham tDCS
In this group subjects will receive 20 min of sham stimulation.




Primary Outcome Measures :
  1. Changes in frequency and severity of the freezing of gait phenomenon [ Time Frame: short (two weeks) after treatment and long term following (11 weeks) after treatment ]
    Clinical assessment of freezing of gait: Gait tasks to provoke FOG (e.g. gait trajectory with dual tasking).


Secondary Outcome Measures :
  1. Changes in cognitive performance [ Time Frame: short (two weeks) after treatment and long term following (11 weeks) after treatment ]
    The NeuroTrax software uses tests of cognitive performance that measure similar cognitive functions to traditional paper-based tests.

  2. Immediate change in gait mesurments [ Time Frame: short (two weeks) after treatment and long term following (11 weeks) after treatment ]
    Gait speed and variability will be assessed under usual and dual task conditions and while negotiating physical obstacles, using a sensorized 7 meter carpet (PKMAS) and wearable body fixed sensors. These measures will be compared to baseline performance.



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Ages Eligible for Study:   25 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria: patients diagnosed with PD, with Hoehn and Yahr Stage between 1-3.5, who suffer from FOG, as measured at screening by the previously validated new FOG questionnaire (NFOG-Q), whose medications have not changed within 1 month of the study and are not anticipated to change during the study, are able to walk independently, and who are between the ages of 40-80 inclusive.

Exclusion Criteria:

Subjects who show no FOG during testing in the lab in response to a FOG provoking protocol, any diagnosed psychiatric or other neurological disorder, stroke, unbalanced and high blood pressure, pregnancy, participation in any clinical trial in the last three months, unwillingness to be randomized; implanted with deep brain stimulation, pacemakers, intracranial electrodes, implanted defibrillators or any other prosthesis; or a perceived inability to complete the study. Additional exclusion criteria related to tDCS safety will include a personal or family history of epilepsy, the use of neuro-active drugs, or risk of metal fragments in the eyes or head.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656316


Contacts
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Contact: Jeffery M Hausdorff, PhD 972-3-6974958 jhausdor@tlvmc.gov.il
Contact: Anat Mirelman, PhD 972-3-6974958 anatmi@tlvmc.gov.il

Locations
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United States, Massachusetts
Institute for Aging Research Recruiting
Boston, Massachusetts, United States, 02131
Contact: Brad Manor, PhD    617-971-5300    bradmanor@hsl.harvard.edu   
Contact: Lewis Lipsitz, MD         
Principal Investigator: Brad Manor, PhD         
Sub-Investigator: Lewis Lipsitz, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Nir Giladi, M.D Head of Neurological institute, Tel-Aviv Sourasky medical center

Publications of Results:
Other Publications:
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Responsible Party: michal roll, Director of Research and Developmen, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02656316     History of Changes
Other Study ID Numbers: TASMC-15-NIR-710-CTIL
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders