An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD

NCT06542991 | Recruiting

• 1 other identifier: PD-OPEN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.

Conditions

Transcranial Magnetic Stimulation; Parkinson Disease; Supplementary Motor Area

Keywords

Transcranial Magnetic Stimulation; Parkinson Disease; Supplementary motor area

Outcome Measures

Primary Outcomes (1)

• Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ

  The primary outcome was the change in MDS-UPDRS III from baseline to 9 weeks of follow-up. MDS-UPDRS III is a questionnaire used by uniformly trained professionals to evaluate motor symptoms in patients with Parkinson's disease\[21\]. The questionnaire consists of 18 items, which professionals need to score according to the patient's motor symptoms, on a scale of 0-4. Among them, items 3.3-3.8 and 3.15-3.17 can be divided into several sub-items according to the body parts. The results of MDS-UPDRS III are the total of 18 items.

  baseline; day 8; week 5;week 9;

Secondary Outcomes (2)

• Hoehn-Yahr(H-Y) stage

  baseline; day 8; week 5;week 9;

• The timed up and go test

  baseline; day 8; week 5;week 9;

Study Arms (1)

rTMS group

EXPERIMENTAL

On the basis of drug treatment, a course of TBS treatment is performed for 7 days.

Other: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation OTHER

During treatment, the patient underwent cTBS targeting the left SMA for 7 consecutive days. Each treatment day comprised six rounds of cTBS, with a 15-minute interval between each. A single cTBS session involved trains of three pulses at 50 Hz, repeated every 200 ms (5 Hz), until reaching a total of 600 pulses, lasting 40s. Stimulation intensity remained at 80% of resting motor threshold. In total, patients received 25,200 pulses throughout the treatment period.

rTMS group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years old
• Meet Movement Disorder Society standards;
• Have no history of drug adjustment within 4 weeks before and during treatment;
• The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
• MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

You may not qualify if:

• Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
• Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
• Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
• There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
• The person or first-degree relatives have a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
• Diagnosed with a neuropsychiatric disorder other than PD
• Have a history of drug abuse or drug use;
• Participants in any clinical trial within the previous 6 month;
• Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic 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)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Kai Wang, Ph.D.

CONTACT

055162923704; wangkai1964@126.com

Panpan Hu, M.D.

CONTACT

13515602285; hpppanda9@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)