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

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 below

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and short (two weeks) after treatment and long term following (11 weeks) after treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in frequency and severity of the freezing of gait phenomenon

Secondary study objectives

Changes in cognitive performance

Immediate change in gait mesurments

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 1

~1190

0 / 1Eligibility criteria met