Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy

C

China Medical University

Status

Unknown

Conditions

Multiple System Atrophy
Parkinson's Disease

Treatments

Device: Transcranial direct current stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03721887
CMUH106-REC2-171

Details and patient eligibility

About

In this project, the investigators will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the leg motor cortex of the FOG patients to examine whether the intervention will benefit the patients in a double blind randomized design. Six assessments with different combinations of clinical scaling, gait analysis, electrophysiological investigation and fMRI examinations before and after tDCS will be conducted. The treatment and placebo groups will be crossed over after one-month washout. The investigators will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is also crucial. The investigators aim to peep the myth of FOG in PD and MSA by the multi-modality approach and hope the study will benefit the long suffering patients.

Enrollment

40 estimated patients

Sex

All

Ages

30 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients meet the diagnosis of PD41 or MSA43 based on the established consensus criteria
  • Age above 30 years old and below 85 years

Exclusion criteria

  • Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations
  • Functional III or above congestive heart failure, or cancer with distant metastasis
  • Hoehn and Yahr stage 5 in PD or MSA

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

real tDCS
Experimental group
Description:
In transcranial direct current stimulation, the anodal pad was tapped over the primary motor cortex and the cathode pad was adhered of the contralateral frontal region. A constant current of 2.0 mA will be apply for up to 20 mins.
Treatment:
Device: Transcranial direct current stimulation
sham tDCS
Sham Comparator group
Description:
In transcranial direct current stimulation, the sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA.
Treatment:
Device: Transcranial direct current stimulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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