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

NCT03721887 | Unknown DMC

• 1 other identifier: CMUH106-REC2-171
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease; Multiple System Atrophy

Keywords

Parkinson's disease; Multiple system atrophy; Freezing of gait; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• EEG recording before and after the tDCS session

  Gait recording by 64 channels EEG device. Four different frequency bands ( theta, alpha, beta, and gamma) will be investigated. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.

  baseline to week 4

Secondary Outcomes (3)

• Electromyography recording before and after the tDCS session

  baseline to week 4

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session

  baseline to week 4

• Change in Unified Multiple System Atrophy Rating Scale (UMSARS) subscores (UMSARS-1 and UMSARS-2) before and after the tDCS session

  baseline to week 4

Other Outcomes (4)

• Change in New freezing of gait questionnaire (NFOG-Q) before and after the tDCS session

  baseline to week 4

• Change in Tinetti's Mobility Index total score before and after the tDCS session

  baseline to week 4

• Change inParkinson's Disease Questionnaire 39 (PDQ-39) before and after the tDCS session

  baseline to week 4

Study Arms (2)

real tDCS

EXPERIMENTAL

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.

Device: Transcranial direct current stimulation

sham tDCS

SHAM COMPARATOR

In transcranial direct current stimulation, the sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA.

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

A consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group.

real tDCS; sham tDCS

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chief, Department of Neurology

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: October 26, 2018
• Study Start: August 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2021
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

TW (1)