NCT02850159

Brief Summary

The purpose of this study is to investigate the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in patients with Parkinson's disease (PD) with freezing of gait (FOG).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable parkinson-disease

Status
completed

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

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed
Last Updated

May 7, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

July 22, 2016

Results QC Date

April 24, 2017

Last Update Submit

April 16, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Change of Freezing of Gait Questionnaire (FOG-Q)

    Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.

    Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5

Study Arms (2)

dual-mode group

EXPERIMENTAL

the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously

Device: rTMS and tDCS

rTMS group

ACTIVE COMPARATOR

high-frequency rTMS and sham tDCS

Device: rTMS

Interventions

rTMS and tDCSDEVICE

Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously

dual-mode group
rTMSDEVICE

Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously

rTMS group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed as Parkinson's disease (PD) with freezing of gait
  • walk independently without walking devices

You may not qualify if:

  • pre-existing and active major neurological diseases other than PD
  • a previous history of seizures
  • implanted metallic objects that would contraindicate rTMS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chang WH, Kim MS, Park E, Cho JW, Youn J, Kim YK, Kim YH. Effect of Dual-Mode and Dual-Site Noninvasive Brain Stimulation on Freezing of Gait in Patients With Parkinson Disease. Arch Phys Med Rehabil. 2017 Jul;98(7):1283-1290. doi: 10.1016/j.apmr.2017.01.011. Epub 2017 Feb 11.

    PMID: 28193533DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic StimulationTranscranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsElectric Stimulation TherapyConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Dr. Won Hyuk Chang
Organization
Samsung Medical Center
wh.chang@samsung.com
82234102818

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 29, 2016

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

May 7, 2024

Results First Posted

July 2, 2017

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share