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Clinical Trail of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Upper Limb Bradykinesia in Parkinson' Disease' Patients

A Randomized Sham-Controlled Trial of High-frequency RTMS in the Treatment of Upper Limb Bradykinesia in Patients with Parkinson's Disease

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06641193
Enrollment
60
Registered
2024-10-15
Start date
2024-08-27
Completion date
2025-08-01
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradykinesia, Parkinson's Disease (PD), Upper Limb Function

Brief 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.

Interventions

DEVICEhigh frequency-repetitive transcranial magnetic stimulation

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.

DEVICEsham stimulation

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.

Sponsors

Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Hoehn and Yahr (HY) stage 1-2 * Able to understand and cooperate with the study * Predominantly characterized by bradykinesia * Onset on the left side

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)2 weeks and 4 weeksChange 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.

Secondary

MeasureTime frameDescription
cortical activation detected by fNIRS2 weeks and 4 weeksUsing near-infrared brain imaging systems, have patients perform finger tapping, fist clenching, and forearm rotation movements to observe brain region activation.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026