NCT02656316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

January 13, 2016

Last Update Submit

October 2, 2019

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Changes in frequency and severity of the freezing of gait phenomenon

    Clinical assessment of freezing of gait: Gait tasks to provoke FOG (e.g. gait trajectory with dual tasking).

    short (two weeks) after treatment and long term following (11 weeks) after treatment

Secondary Outcomes (2)

  • Changes in cognitive performance

    short (two weeks) after treatment and long term following (11 weeks) after treatment

  • Immediate change in gait mesurments

    short (two weeks) after treatment and long term following (11 weeks) after treatment

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

The Sham tDCS - an inactive stimulation.

Device: Sham tDCS

Interventions

Active tDCSDEVICE

In this group subjects will receive 20 min of treatment.

Active tDCS
Sham tDCSDEVICE

In this group subjects will receive 20 min of sham stimulation.

Sham tDCS

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Aging Research

Boston, Massachusetts, 02131, United States

Location

Related Publications (4)

  • Weiss 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: 25069586BACKGROUND

  • Leite 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: 24332532RESULT

  • 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: 24443958RESULT

  • Manor B, Dagan M, Herman T, Gouskova NA, Vanderhorst VG, Giladi N, Travison TG, Pascual-Leone A, Lipsitz LA, Hausdorff JM. Multitarget Transcranial Electrical Stimulation for Freezing of Gait: A Randomized Controlled Trial. Mov Disord. 2021 Nov;36(11):2693-2698. doi: 10.1002/mds.28759. Epub 2021 Aug 18.

    PMID: 34406695DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Nir Giladi, M.D

    Head of Neurological institute, Tel-Aviv Sourasky medical center

    PRINCIPAL INVESTIGATOR

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 Developmen

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 14, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

October 3, 2019

Record last verified: 2019-10

Locations

US(1)