The Effect of tDCS on a Motor-cognitive Dual-task Performance of Parkinson's Patients
The Effect of Transcranial Direct Cortical Stimulation (tDCS) on a Motor-cognitive Dual-task Performance of Parkinson's Patients
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The concurrent performance of two tasks, i.e., dual tasking (DT), is a common and ubiquitous every day phenomena. For example, people frequently walk while talking on a cellphone or drive while talking to a passenger. Often, the performance of one or more of these simultaneously performed tasks may deteriorate when another task is carried out at the same time, even in healthy young adults. This reduction in performance is referred to as the DT deficit or DT cost and is typically much higher in patients with Parkinson's disease (PD) than in young adults or age-matched controls. In PD, this DT cost impairs the gait pattern, as manifested, for example, in increased gait variability, exacerbating instability and fall risk. In the proposed study, would be evaluated the effects of tDCS on dual tasking performance following tDCS. The researchers expect that stimulation of the Pre Frontal Cortex (PFC) (using tDCS) will increase DT performance and prefrontal activation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jul 2015
Longer than P75 for not_applicable parkinson-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJuly 21, 2015
July 1, 2015
3 years
July 9, 2015
July 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in frequency and severity of the freezing of gait phenomenon
The new version of the Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to baseline.
One week post intervention
Secondary Outcomes (5)
fMRI scans - changes in gray matter (GM) volume
One week post intervention
fNIRS related frontal lobe activation - changes in tissue oxygenation
One week post intervention
Changes in cognitive performance
One week post intervention
Immediate change in gait speed
One week post intervention
Immediate change in gait variability
One week post intervention
Study Arms (2)
Active tDCS
EXPERIMENTALThe 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.
Sham tDCS
SHAM COMPARATORThe Sham tDCS - an inactive stimulation.
Interventions
In this group subjects will receive 20 min of treatment.
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic PD (defined by the UK Brain Bank criteria)
- Hoehn and Yahr score between 1.5-3
- Taking anti-parkinsonian medications.
You may not qualify if:
- Mini Mental State Exam (MMSE) score =\< 24
- Brain surgery in the past including implanted DBS
- Major depression (DSM-IV Criteria)
- Cerebral Infarction with Residual Deficits Diagnosis
- Neurological diseases (except from PD)
- Orthopaedic or cardiovascular diseases that may affect walking and cognitive abilities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Tel Aviv Universitycollaborator
Related Publications (4)
Zhou J, Hao Y, Wang Y, Jor'dan A, Pascual-Leone A, Zhang J, Fang J, Manor B. Transcranial direct current stimulation reduces the cost of performing a cognitive task on gait and postural control. Eur J Neurosci. 2014 Apr;39(8):1343-8. doi: 10.1111/ejn.12492. Epub 2014 Jan 20.
PMID: 24443958BACKGROUNDLeite J, Goncalves OF, Carvalho S. Facilitative effects of bi-hemispheric tDCS in cognitive deficits of Parkinson disease patients. Med Hypotheses. 2014 Feb;82(2):138-40. doi: 10.1016/j.mehy.2013.11.021. Epub 2013 Dec 1.
PMID: 24332532RESULTSpringer S, Giladi N, Peretz C, Yogev G, Simon ES, Hausdorff JM. Dual-tasking effects on gait variability: the role of aging, falls, and executive function. Mov Disord. 2006 Jul;21(7):950-7. doi: 10.1002/mds.20848.
PMID: 16541455RESULTWeiss A, Herman T, Giladi N, Hausdorff JM. New evidence for gait abnormalities among Parkinson's disease patients who suffer from freezing of gait: insights using a body-fixed sensor worn for 3 days. J Neural Transm (Vienna). 2015 Mar;122(3):403-10. doi: 10.1007/s00702-014-1279-y. Epub 2014 Jul 29.
PMID: 25069586RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nir Giladi, M.D
Tel Aviv Sourasky medical Center, Tel Aviv, Israel. Phone: 972-3-6974790
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research and Development
Study Record Dates
First Submitted
July 9, 2015
First Posted
July 21, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2018
Study Completion
October 1, 2018
Last Updated
July 21, 2015
Record last verified: 2015-07