The Efficacy of Repetitive Transcranial Magnetic Stimulation With Precision Neuronavigation in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

A Randomized, Double-blind, Multicenter, Placebo-controlled Trial: the Efficacy of Repetitive Transcranial Magnetic Stimulation With Precision Neuronavigation in Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383247
• Other study ID #: AMU-PD-multicenter
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2024
• Source: Anhui Medical University
• Contact: Panpan Hu, M.D.
• Phone: +8613515602285
• Email: hpppanda9[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country.

Description:

This is a multi-center, double-blind, randomized controlled study that will be implemented in multiple hospital centers in China. In this study, the supplementary motor area (SMA) of the dominant hemisphere was selected as the stimulation target, and continuous theta burst stimulation (cTBS) sequence contact stimulation was used for a course of continuous stimulation for 7 days to observe the changes in clinical symptoms before and after the intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 312
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• transcranial magnetic stimulation
The stimulations were performed by MagStim Rapid2.

Locations

Country	Name	City	State
China	Cognitive Neuropsychology Lab Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores	This is an very common clinical motor estimating scale with 18 items and 140' in total. Higher scores indicate worse symptoms.	baseline; week 3; week 6;week 10;week 14
Secondary	Movement Disorder Society- Unified Parkinson's Disease Rating Scale ? scores	MDS-UPDRS I is used to evaluate the daily life non-motor symptom experience of patients with Parkinson's disease. It includes 13 items with a total score of 52 points. Higher scores indicate worse symptoms.	baseline; week 3; week 6;week 10;week 14
Secondary	Movement Disorder Society- Unified Parkinson's Disease Rating Scale ? scores	MDS-UPDRS II is used to evaluate patients' experience of daily life motor symptoms, such as speech function, eating ability, daily living ability (eating, dressing, hygiene), tremor, walking, etc. It includes 13 items with a total score of 52 points. Higher scores indicate worse symptoms.	baseline; week 3; week 6;week 10;week 14
Secondary	Movement Disorder Society- Unified Parkinson's Disease Rating Scale ? scores	The MDS-UPDRS IV questionnaire assesses the severity of two motor complications in patients: dyskinesias and motor fluctuations, combined with previously known and objective information. It includes 6 items with a total score of 24 points. Higher scores indicate worse symptoms.	baseline; week 3; week 6;week 10;week 14