An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Transcranial Magnetic Stimulation, Parkinson Disease, Supplementary Motor Area. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ [Time frame: baseline; day 8; week 5;week 9;]
Secondary outcome measures (2)
- Hoehn-Yahr(H-Y) stage [Time frame: baseline; day 8; week 5;week 9;]
- The timed up and go test [Time frame: baseline; day 8; week 5;week 9;]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- Other conditions deemed unsuitable for inclusion by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cognitive Neuropsychology Lab Anhui Medical University — Hefei
Identifiers
NCT: NCT06542991 · PD-OPEN