Exploring the Possible Beneficial Impact of Non-invasive and Invasive Neuromodulation on Freezing of Gait in Parkinson's Disease During Different Ambulatory Complexities: An Electrophysiological and fMRI Study

NCT06505460 | Recruiting DMC

• 1 other identifier: CMUH112-REC2-213
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Freezing of gait (FOG) stands out as a devastating symptom of Parkinson's disease (PD), where patients may become momentarily glued to the ground, rendering them incapable of walking efficiently. The pathogenesis of FOG remains uncertain but is likely attributed to functional perturbations in superficial cortical and deep locomotion regions. FOG tends to manifest more prominently during complex walking, such as turning, than during simple straight forward walking, and the reasons for this phenomenon remain unclear. Unfortunately, effective methods for overcoming this ambulatory issue has yet to be identified, and quantifying paroxysmal gait spells proves challenging with clinical rating alone; thus, a scientific tool is warranted. In this 3-year proposal, the investigators plan to address these challenges comprehensively.

Conditions

Transcranial Direct Current Stimulation

Keywords

Parkinson's disease; freezing of gait; MRI; tDCS; focused ultrasound; DBS

Outcome Measures

Primary Outcomes (4)

• 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

• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session UPDRS contains four parts, the third part of which is reported in this outcome.

  UPDRS contains four parts, the third part of which is reported in this outcome. Part III is clinician-scored monitored motor evaluation (14 questions, ranges from 0=normal to 4= Severe). The scoring of Part III varies between 0-56. The higher score indicates the worse motor function. Negative change from baseline values indicate improvement.

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

Secondary Outcomes (2)

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

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

• Change in Gait and Falls Questionnaire (GFQ) before and after the tDCS session

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

Other Outcomes (4)

• 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 in Berg Balance Scale 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 constant current of 2.0 mA was applied to each site for up to 20 minutes.

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: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients meet the diagnosis of PD based on the established consensus criteria
• Age above 20 years old and below 90 years
• For MRgFUS patients: a. At least one of the 3 cardinal symptoms (akinesia, tremor, rigidity) reaches an intensity of at least 2/4. b. Parkinsonian symptoms cannot be satisfactorily controlled by optimal pharmacological treatment including L-dopa and other antiparkinsonian drugs. c. stable medication for PD ≥ 30 days.
• DBS patients must meet Taiwan Health Insurance criteria: PD duration exceeding 5 years, positive response to levodopa (≥33% UPDRS motor score improvement), and presence of motor complications (e.g., wearing off, on-off, levodopa-related dyskinesia, or medically intractable tremor).

You may not qualify if:

• Congestive heart failure (Functional III or above) or advanced cancer with distant metastasis.
• PD at Hoehn and Yahr Stage 5.

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

Conditions

Parkinson Disease

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Chon-Haw Tsai, PHD

CONTACT

8864-22052121; 008079@tool.caaumed.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: July 11, 2024
• First Posted: July 17, 2024
• Study Start: April 30, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

TW (1)