Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease

NCT04431570 | Unknown

• 1 other identifier: rTMSPDFOG-PUMCH
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit, especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD patients. In the present randomized controlled trial (RCT) study, the invastigators aim to investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the effects of rTMS over different brain regions will be compared for choosing a better target. The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease with freezing of gait (PD-FOG).

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Keywords

freezing of gait; FMRI; rTMS

Outcome Measures

Primary Outcomes (1)

• the change of freezing of gait questionnaire (FOGQ)

  a self-assessment scale for evaluating FOG severity，the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.

  through study completion, an average of 2 weeks

Secondary Outcomes (6)

• the change of freezing of gait score (FOG score)

  through study completion, an average of 2 weeks

• the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III

  through study completion, an average of 2 weeks

• the change of Hamilton Depression (HAMD) Scale

  through study completion, an average of 2 weeks

• the change of Mini-mental State Examination (MMSE) scale

  through study completion, an average of 2 weeks

• the change of Parkinson's Disease Questionnaire (PDQ-39)

  through study completion, an average of 2 weeks

Study Arms (3)

rTMS over M1 region

EXPERIMENTAL

The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region.

Device: rTMS

rTMS over supplementary motor area (SMA)

EXPERIMENTAL

The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region.

Device: rTMS

sham stimulation

SHAM COMPARATOR

Device: sham stimulation

Interventions

rTMS DEVICE

The device is made in London, United Kingdom

rTMS over M1 region; rTMS over supplementary motor area (SMA)

sham stimulation DEVICE

the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil

sham stimulation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria
• Hoehn \& Yahr (H-Y) stage was 2 or 3
• All subjects had freezing of gait which was identified by FOGQ

You may not qualify if:

• cognitive impairment (MMSE score\<22) or major depression (HAMD-24 score\>25)
• severe visual and/or haring impairment
• significant medical or psychiatric illnesses
• history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients
• current treatment with medication cannot be maintained during the study

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Han Wang, doctor

CONTACT

+8618600044179; 18600044179@163.com

Dan Xu, doctor

CONTACT

+8618614069673; pumc04xd@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: June 16, 2020
• Study Start: June 15, 2020
• Primary Completion: April 14, 2022
• Study Completion: June 14, 2022
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CN (1)