A Trial of tPCS on Parkinson's Disease OFF State

NCT04054960 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-08-13

No results posted yet for this study

Summary

A significant number of patients with Parkinson's disease (PD) face motor fluctuations even after repeated titration of the dosing of Levodopa. Dealing with OFF state really becomes problematic for them. Aggravation of bradykinesia, rigidity, tremor and gait difficulty are the common problems in OFF state. Studies are going on drugs like Apomorphine as rescue therapy in OFF state. Recently there are studies with Noninvasive brain stimulation, as an evolving therapeutic option in different neurodegenerative diseases. In this study, the investigators are to evaluate the efficacy of transcranial pulsed current stimulation (tPCS) in the OFF state in PD patients. The investigators will give stimulation via tPCS (active/sham). EEG, Kinematic measurement of upper limb movement via KinArm, Unified Parkinson's Disease Rating Scale (UPDRS) scoring will be done and gait will be assessed via Gait Carpet - pre and post-stimulation. The investigators will evaluate the effectiveness of tPCS as a single modality or in combination with Levodopa in managing OFF state of PD.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Active tPCS

Active anodal tPCS will be given for 20 mins to motor cortex (M1) or supplementary motor area (SMA), based on our quantitative EEG findings.

DEVICE

Sham tPCS

For the sham condition, the electrode placement will be the same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation.

DRUG

Levodopa tablet

We will give 3 tablets of Levodopa-Carbidopa (100/25).

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Principal Investigators

  • Mandar Jog, MD · London Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2021-09-30
Completion
2021-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054960 on ClinicalTrials.gov