NCT02969941

Brief Summary

To investigate the treatment effect of continuous transcranial magnetic stimulation on patients with Parkinson disease, and the underlying neural mechanism by functional MRI

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

2.6 years

First QC Date

November 17, 2016

Last Update Submit

March 16, 2019

Conditions

Transcranial Magnetic StimulationFunctional Magnetic Resonance ImagingParkinson Disease

Keywords

Parkinson DiseaseFunctional Magnetic Resonance ImagingTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Symptom improvement assessed by Unified Parkinson's Disease Rating Scale III

    This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.

    changes from baseline at 2 weeks post-treatment

Secondary Outcomes (4)

  • Timed up and go test

    changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment

  • 20m walking test

    changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment

  • Non-motor symptoms questionnaire

    changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment

  • Unified Parkinson's Disease Rating Scale III

    changes from baseline at 1, 4, 6, and 10 weeks post-treatment

Study Arms (2)

Real Stimulation

ACTIVE COMPARATOR

Participants will receive active transcranial magnetic stimulation (TMS) daily for two weeks

Other: transcranial magnetic stimulation

Placebo Stimulation

PLACEBO COMPARATOR

Participants will receive sham transcranial magnetic stimulation (TMS) daily for two weeks

Other: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulationOTHER

The stimulations were performed by MagStim Rapid2.

Placebo StimulationReal Stimulation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson disease (PD) according to the United Kingdom Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders.
  • Minimum of 3 years since the formal diagnosis of PD, and requiring dopaminergic therapy (at a minimum, on levodopa and/or dopamine agonist therapy).
  • On a stable dose of all medications for 2 months; and no anti-PD medication adjustments in the next 3 months.
  • Age 40 years or older.
  • Mini-mental state examination \> 27.

You may not qualify if:

  • Any history or clinical signs of other severe psychiatric illnesses (like major depression, psychosis or obsessive compulsive disorder).
  • History of head injury, stroke, or other neurologic disease.
  • Organic brain defects on T1 or T2 images.
  • History of seizures or unexplained loss of consciousness.
  • Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator.
  • Family history of medication refractory epilepsy.
  • History of substance abuse within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

Location

Related Publications (1)

  • Yu L, Han J, Chen X, Hu L, Wang M, Zhu M, Cheng J, Liu P, Fang L, Li Y, Wu J, Zhao X, Sun J, Ji GJ, Wang K, Ye R, Hu P. Regional-specific structural and functional changes of posterior cerebellar vermis across different stages of Parkinson's disease with gait dysfunction. NPJ Parkinsons Dis. 2025 Jul 12;11(1):208. doi: 10.1038/s41531-025-01065-1.

    PMID: 40651960DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of medical psychological department

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)