Parkinson's Disease (PD)NCT06641193
Clinical Trail of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Upper Limb Bradykinesia in Parkinson' Disease' Patients
A study testing high frequency-repetitive transcranial magnetic stimulation in people with Parkinson's Disease (PD) and Bradykinesia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
A randomized, double-blind, sham-controlled unicenter clinical trial was used to investigate the effectiveness and neural mechanism of high-frequency repetitive transcranial magnetic stimulation in the treatment of upper limb bradykinesia in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson's Disease (PD), Bradykinesia, Upper Limb Function
- What is being tested?
- high frequency-repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hoehn and Yahr (HY) stage 1-2
- Able to understand and cooperate with the study
- Predominantly characterized by bradykinesia
- Onset on the left side
Who cannot join
- Contraindications for TMS including DBS surgery, Ventriculoperitoneal shunt, etc
- Other neurological disorders
- Significant resting tremor, with MDS-UPDRS-III tremor score ≥3
- Resting threshold cannot be measured
- Received other TMS treatments within the last 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
About this study
Official title: A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease
A randomized, double-blind, sham-controlled unicenter clinical trial was used to investigate the effectiveness and neural mechanism of high-frequency repetitive transcranial magnetic stimulation in the treatment of upper limb bradykinesia in patients with Parkinson's disease.
- Being tested
- high frequency-repetitive transcranial magnetic stimulation, sham stimulation
- Medical subject headings
- Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency-repetitive transcranial magnetic stimulationDevice
rTMS involves the repeated application of magnetic pulses to specific areas of the brain. These pulses are delivered using a coil placed on the scalp, which generates a magnetic field that induces electrical currents in the brain tissue.
sham stimulationDevice
The sham group receives 10 sessions of rTMS stimulation with a sham stimulation coil, which emits the same sound and vibration as the active coil but does not produce any induced electrical currents.
| Study group | Role | What they receive |
|---|---|---|
| verum group | Experimental | verum group receive real 10 sessions of rTMS stimulation. once daily for 5 consecutive days a week. Receives: Device: high frequency-repetitive transcranial magnetic stimulation |
| sham group | Sham comparator | The sham group receives 10 sessions of rTMS stimulation, once daily for 5 consecutive days a week. However, a sham stimulation coil is used, which emits the same sound and vibration as the active coil but does not produce any induced electrical currents. Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.
Measured: 2 weeks and 4 weeks
Secondary outcomes (1)
cortical activation detected by fNIRS
Using near-infrared brain imaging systems, have patients perform finger tapping, fist clenching, and forearm rotation movements to observe brain region activation.
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start27 Aug 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Zhengguo Liu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641193
- Sponsor's protocol ID
- XHEC-C-2024-125-2-2
- Status last verified
- Aug 2024
- First submitted
- 11 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06641193
- Acronym / sponsor ID
- XHEC-C-2024-125-2-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, sham-controlled unicenter clinical trial was used to investigate the effectiveness and neural mechanism of high-frequency repetitive transcranial magnetic stimulation in the treatment of upper limb bradykinesia in patients with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum group | Experimental | Device: high frequency-repetitive transcranial magnetic stimulationverum group receive real 10 sessions of rTMS stimulation. once daily for 5 consecutive days a week. |
| sham group | Sham comparator | Device: sham stimulationThe sham group receives 10 sessions of rTMS stimulation, once daily for 5 consecutive days a week. However, a sham stimulation coil is used, which emits the same sound and vibration as the active coil but does not produce any induced electrical currents. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hoehn and Yahr (HY) stage 1-2
- Able to understand and cooperate with the study
- Predominantly characterized by bradykinesia
- Onset on the left side
Key exclusion criteria (5 listed)
- Contraindications for TMS including DBS surgery, Ventriculoperitoneal shunt, etc
- Other neurological disorders
- Significant resting tremor, with MDS-UPDRS-III tremor score ≥3
- Resting threshold cannot be measured
- Received other TMS treatments within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high frequency-repetitive transcranial magnetic stimulationrTMS involves the repeated application of magnetic pulses to specific areas of the brain. These pulses are delivered using a coil placed on the scalp, which generates a magnetic field that induces electrical currents in the brain tissue. | Device | verum group |
| sham stimulationThe sham group receives 10 sessions of rTMS stimulation with a sham stimulation coil, which emits the same sound and vibration as the active coil but does not produce any induced electrical currents. | Device | sham group |
Primary outcome
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 2 weeks and 4 weeks
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.
1 secondary outcome
cortical activation detected by fNIRS
Time frame: 2 weeks and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high frequency-repetitive transcranial magnetic stimulation in people with Parkinson's Disease (PD) and Bradykinesia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: 2 weeks and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.