Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effect of Simultaneous Dual Stimulation on Freezing of Gait in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850159
• Other study ID #: 2013-09-122
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: November 2015

Study information

• Verified date: April 2024
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Patients in the dual-mode group underwent five consecutive daily sessions of dual-mode NIBS with simultaneous high-frequency rTMS and tDCS, whereas patients in the rTMS group underwent high-frequency rTMS with sham tDCS. Assessments of FOG, motor, ambulatory and cognitive function were performed three times: at baseline before NIBS, immediately after NIBS, and one week after cessation of NIBS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• diagnosed as Parkinson's disease (PD) with freezing of gait

• walk independently without walking devices

Exclusion Criteria:

• pre-existing and active major neurological diseases other than PD

• a previous history of seizures

• implanted metallic objects that would contraindicate rTMS

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• rTMS and tDCS
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
• rTMS
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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