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

NCT05092243 | Unknown DMC

• 1 other identifier: CMUH110-REC3-010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (3)

• Electroencephalogram 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 / 2 days, 2 and 4 weeks after the end of the tDCS session

• Electromyography recording before and after the tDCS session

  The 4 pairs of leg EMG recording during 50 meters walking. The EMG signals will be filtered with a band pass ranging from 0.05 to 70 Hz. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.

  baseline / 2 days, 2 and 4 weeks after the end of the tDCS session

• Functional magnetic resonance images examination before and after the tDCS session

  fMRI scan will be performed on a 3.0T MR imager to detect the brain BOLD signal change in FOG. When fMRI was conducted, four different video tapes will be presented to the subjects：1.normal walking, 2.normal turning, 3.FOG during forward straight walking and 4.FOG during turning.

  baseline / 2 days after the end of the tDCS session

Secondary Outcomes (2)

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

  baseline / 2 days, 2 and 4 weeks after the end of the tDCS session

• Change in Progressive Supranuclear Palsy Rating Scale (PSPRS)

  baseline / 2 days, 2 and 4 weeks after the end of the tDCS session

Other Outcomes (4)

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

  baseline / 4 weeks after the end of the tDCS session

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

  baseline / 4 weeks after the end of the tDCS session

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

  baseline / 4 weeks after the end of the tDCS session

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 PD or PSP based on the established consensus criteria

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 PSP

Sponsors & Collaborators

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

Study Sites (1)

China Medical University Hospital/Neuro Depart

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chon-Haw Tsai, PHD

  The chief, Department of Neurology, China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chon-Haw Tsai, PHD

CONTACT

8864-22052121; d8079@mail.cmuh.org.tw

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: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 25, 2021
• Study Start: August 30, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2024
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

TW (1)