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

August 3, 2024 updated by: WANG KAI, Anhui Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease.

We describe a open-lable study designed to recruit 20 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Cognitive Neuropsychology Lab Anhui Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS group
On the basis of drug treatment, a course of TBS treatment is performed for 7 days.
Other: transcranial magnetic stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ
Time Frame: baseline; day 8; week 5;week 9;
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hoehn-Yahr(H-Y) stage
Time Frame: baseline; day 8; week 5;week 9;
It ranges from 1 to 5, and is evaluated based on the range of symptoms involved and whether balance is impaired in PD patients. The higher the score, the more severe the severity.
baseline; day 8; week 5;week 9;
The timed up and go test
Time Frame: baseline; day 8; week 5;week 9;
TUG measures in seconds how long it takes the subject to rise from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test is often used to assess walking and balance in older adults. This also applies to evaluating the severity of walking and balance symptoms in patients with Parkinson's disease.
baseline; day 8; week 5;week 9;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-OPEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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