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Noninvasive Brain Stimulation
Active tDCS for Parkinson's Disease
N/A
Waitlist Available
Led By Nir Giladi, M.D
Research Sponsored by Tel-Aviv Sourasky Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up short (two weeks) after treatment and long term following (11 weeks) after treatment
Awards & highlights
Study 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.
Eligible Conditions
- Parkinson's Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ short (two weeks) after treatment and long term following (11 weeks) after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~short (two weeks) after treatment and long term following (11 weeks) after treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in frequency and severity of the freezing of gait phenomenon
Secondary outcome measures
Changes in cognitive performance
Immediate change in gait mesurments
Side effects data
From 2012 Phase 3 trial • 60 Patients • NCT0164923210%
headache
10%
headedness / dizziness
7%
fatigue or nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active tDCS
Controls
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
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.
Group II: Sham tDCSPlacebo Group1 Intervention
The Sham tDCS - an inactive stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active tDCS
2012
Completed Phase 3
~1150
Find a Location
Who is running the clinical trial?
Tel-Aviv Sourasky Medical CenterLead Sponsor
566 Previous Clinical Trials
307,144 Total Patients Enrolled
Nir Giladi, M.DPrincipal InvestigatorHead of Neurological institute, Tel-Aviv Sourasky medical center
1 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
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