NCT05092243

Exploit the Functional Higher Neural Connectivity and Electrophysiological Intervention of Freezing of Gait in PD and PSP During Different Ambulatory Complexities

Status unknown NA Last updated 25 October 2021

What this trial tests

NA trial testing Transcranial direct current stimulation in Transcranial Direct Current Stimulation in 40 participants. Status unknown.

Timeline

30 August 2021

Primary endpoint
31 July 2022

31 July 2024

Quick facts

Lead sponsor	China Medical University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	30 August 2021
Primary completion	31 July 2022
Estimated completion	31 July 2024
Sites	1 location across Taiwan

Drugs / interventions tested

• Transcranial direct current stimulation

Conditions studied

• Transcranial Direct Current Stimulation — all drugs for Transcranial Direct Current Stimulation →

Sponsor

China Medical University Hospital

Who can join

Adults 30 to 85, any sex, with Transcranial Direct Current Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the current proposal, investigators will investigate three crucial issues of FOG. Firstly, investigators will identify the possible source(s) of FOG in PD and PSP patients during unconstrained walking using a 64-channel ambulatory recorder. The investigators will explore the electric neural sources of FOG and brain connectivity. Secondarily, fMRI during motor imagery will be performed to examine the brain regions involved in the FOG patients. The investigators will merge the electrophysiological and imaging findings to detect the possible neurovascular coupling or uncoupling. Thirdly, electric intervention with transcranial direct current stimulation (tDCS) will be conducted to see whether the FOG situation can be ameliorated in PD and PSP patients. The investigators will deliver a 5-day session of 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. Besides, there is no long-term cohort investigation of tDCS on neurodegenerative patients with FOG. The investigators will have a 3-year follow-up with a 1-month interval open-label stimulation paradigm for the patients who remained voluntarily after the termination of the initial short-term trials.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.