NCT06009471

Brief Summary

Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

August 24, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

June 25, 2023

Last Update Submit

August 20, 2023

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaserepetitive transcranial magnetic stimulation(rTMS)Unified Parkinson's Disease Rating Scale (UPDRS)Montreal Cognitive Assessment Scale (MoCA)activity of daily living(ADL)PD Sleep Scale (PDSS)King's Parkinson's Pain Assessment (KPPS)

Outcome Measures

Primary Outcomes (5)

  • Unified Parkinson's disease rating Scale （UPDRS）

    16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.

    The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

  • Montreal Cognitive Assessment Scale (MoCA)

    Full score of 30 points,\>=26 points normal,. Mild cognitive impairment (MCI) on a scale of 18-26, moderate on a scale of 10-17, and severe on a scale of\<10.

    The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

  • King's Parkinson's Pain Assessment (KPPS)

    Evaluate the pain degree and quality of life of patients with Parkinson's disease, including 14 items in 7 aspects, including skeletal muscle pain, Chronic pain, symptom fluctuation related pain, nocturnal pain, orofacial pain, distention pain, and nerve root pain. Each score is expressed as pain severity (0-3 levels) multiplied by frequency (0-4 levels), that is, 0-12 points. The total score is 168 points. The higher the score, the more severe the pain.

    The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

  • PD Sleep Scale (PDSS)

    Evaluate the patient's sleep status, with a total of 15 items on the scale. Each item is scored on a scale of 0-10 points, with a lower score indicating poorer sleep status.

    The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

  • Activities of daily living Assessment - Barthel

    The total score of the index is 100 points, and the higher the score, the better the self-care ability and the less dependence. Those scoring above 60 can basically complete basic Activities of daily living, 59-41 need some help to complete, 40-21 need a lot of help. Those who score below 20 are in complete need of help and cannot take care of themselves.

    The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

Secondary Outcomes (2)

  • Hamilton Depression Scale (HAMD)

    The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

  • Hamilton Anxiety Scale (HAMA)

    The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.

Study Arms (2)

Control group

ACTIVE COMPARATOR

All participants were treated with routine treatment in Neurology.

Other: Routine treatment in Neurology

Experimental group

EXPERIMENTAL

All participants were treated with routine treatment in Neurology and rTMS treatment. rTMS parameters were set to stimulate the site: bilateral primary motor cortex; Stimulus frequency :5Hz; Pulse number: 1000 pulses per day, 500 on the left and 500 on the right; Stimulus intensity :90% resting threshold; Coil: 70mm round coil; Once a day, 30 minutes each time, 5 days a week for 4 weeks

Device: Routine treatment in Neurology and rTMS

Interventions

Routine treatment in NeurologyOTHER

Routine treatment in Neurology department, including drug treatment,etc.

Control group
Routine treatment in Neurology and rTMSDEVICE

Add rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability

Experimental group

Eligibility Criteria

Age30 Years - 80 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hoehn-YAHR classification is between 1 and 2；
  • Have a primary school education or above and can read the scale used in this study;
  • MoCA score between 20 and 24, mild cognitive impairment ;
  • Aged between 30 and 80, regardless of gender；
  • Voluntarily participate and sign informed consent.

You may not qualify if:

  • patients with cerebrovascular accident, craniocerebral injury and other diseases affecting muscle tension;
  • patients with serious mental disorders and cognitive disorders who cannot cooperate with assessment;
  • patients with severe liver, kidney, heart dysfunction and severe physical disorders;
  • Implanted devices such as pacemakers are installed inside the body;
  • drug-induced Parkinson's syndrome or Parkinson's superposition syndrome;
  • Have a history of epilepsy;
  • Women during pregnancy and breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

rTMS

Nantong, Jiangsu, 226001, China

RECRUITING

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

Central Study Contacts

Aisong Guo

CONTACT

15851300188guoasg@ntu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 200 patients with Parkinson's disease were enrolled in each center and randomly divided into control group (routine treatment) and observation group (routine treatment +rTMS).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2023

First Posted

August 24, 2023

Study Start

July 1, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

August 24, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)