Individualized Transcranial Magnetic Stimulation in Parkinsonian Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorPeking University First Hospital
About this trial
This clinical trial aims to evaluate whether individualized targeted repetitive transcranial magnetic stimulation (rTMS) can improve motor and non-motor symptoms in patients with parkinsonian disorders. The main question it aims to answer is:
* Does individualized targeted rTMS alleviate symptoms of parkinsonian disorders? * Which clinical manifestations of parkinsonian syndromes are responsive to individualized targeted rTMS, and to what degree?
Procedures:
* Preparation (Screening) Participants will undergo clinical assessments, MRI, and EEG before the treatment. * Treatment (2 Weeks) Participants will receive a 10-day TMS treatment (once daily, Monday-Friday). Each treatment day takes approximately 3-4 hours. Participants need to keep stable medications and rehabilitation routines during this time. * Follow-up (10 Weeks) Participants will undergo follow-up assessments at the end of treatment and 10 weeks after treatment. Assessments include clinical scales, MRI, and EEG.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnostic Criteria Clinically established or clinically probable Parkinson's Disease (PD) according to the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria; Clinically established or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria; Clinically probable or clinically possible Progressive Supranuclear Palsy (PSP) according to the 2017 MDS diagnostic criteria.
Demographics Aged 30 to 80 years, inclusive; no gender restrictions.
Disease Severity and Staging PD: Modified Hoehn and Yahr (H-Y) stage 2-4; MSA: Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV stage 1-4; PSP: Modified Rankin Scale (mRS) grade 2-4.
Informed Consent and Compliance Ability to understand and comply with the study requirements and provide written informed consent.
Disqualifiers
Contraindications to TMS Presence of intracranial metallic implants or other foreign bodies, including but not limited to cochlear implants, cardiac pacemakers, or internal metallic/magnetic fragments.
Contraindications to EEG and MRI EEG: Known allergy to conductive paste or other EEG-related contraindications. MRI: History of claustrophobia, presence of MRI-incompatible implants, or extensive tattoos.
Concurrent Physical Therapies Currently receiving Transcranial Magnetic Stimulation (TMS) or other therapeutic physical modalities, such as Transcranial Direct Current Stimulation (tDCS).
Unstable Medical Conditions Presence of unstable systemic diseases requiring urgent pharmacological or surgical intervention.
Trial design
Design model
Single group
Treatments tested in this trial
TMS
DeviceIntermittent theta burst stimulation (iTBS) will be delivered using a figure-of-eight coil targeting the individualized somato-cognitive action network sites (involving superior and central region) in the left hemisphere. Stimulation intensity will be set at 100% of the resting motor threshold. The iTBS protocol will consist of bursts of 3 pulses at 50 Hz, repeated at 5 Hz. Each stimulation train include 10 bursts, with an inter-train interval of 8 seconds. A total of 60 trains will be delivered, resulting in 1800 pulses per session, with four consecutive sessions and a 50-minute interval between sessions, yielding 7200 pulses per target, and a total of 14,400 pulses per day, over ten consecutive working days.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: individualized rTMSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in motor symptoms measured by MDS-UPDRS Part III
Motor symptoms will be assessed using the Movement Disorder Society-sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame
Baseline to post-treatment and 10 weeks after treatment2
Change in mobility measured by the 5-meter Timed Up and Go test
Mobility will be assessed using the 5-meter Timed Up and Go test. The result is recorded as the time in seconds required to stand up from a chair, walk 5 meters, turn around, walk back, and sit down. The theoretical minimum value is 0 seconds, and there is no fixed maximum value. A longer time indicates poorer mobility and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame
Baseline to post-treatment and 10 weeks after treatment3
Change in non-motor symptoms measured by the Non-Motor Symptoms Questionnaire
Non-motor symptoms will be assessed using the Non-Motor Symptoms Questionnaire. The total score ranges from 0 to 30, with higher scores indicating a greater burden of non-motor symptoms and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame
Baseline to post-treatment and 10 weeks after treatmentSecondary outcomes
1
Change in motor symptoms measured by UMSARS Part II
Motor impairment in patients with multiple system atrophy will be assessed using the Unified Multiple System Atrophy Rating Scale (UMSARS) Part II. The total score ranges from 0 to 56, with higher scores indicating more severe motor impairment and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame
Baseline to post-treatment and 10 weeks after treatment2
Change in disease severity measured by PSPRS
Disease severity in patients with progressive supranuclear palsy will be assessed using the Progressive Supranuclear Palsy Rating Scale (PSPRS). The total score ranges from 0 to 100, with higher scores indicating greater disease severity and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame
Baseline to post-treatment and 10 weeks after treatment3
Change in balance measured by the Berg Balance Scale
Balance function will be assessed using the Berg Balance Scale. The total score ranges from 0 to 56, with higher scores indicating better balance performance and a better outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame
Baseline to post-treatment and 10 weeks after treatment4
Change in ataxia severity measured by SARA
Ataxia severity will be assessed using the Scale for the Assessment and Rating of Ataxia (SARA). The total score ranges from 0 to 40, with higher scores indicating more severe ataxia and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Time frame
Baseline to post-treatment and 10 weeks after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Changping Laboratory
Collaborator
Source ClinicalTrials.gov