The Effects of Multi-focal tDCS on Motor-cognitive Dysfunctions in Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT02656316|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2016
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Active tDCS Device: Sham tDCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- 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).
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656316
|United States, Massachusetts|
|Institute for Aging Research|
|Boston, Massachusetts, United States, 02131|
|Principal Investigator:||Nir Giladi, M.D||Head of Neurological institute, Tel-Aviv Sourasky medical center|