The Effect of Multi-target Magnetic Stimulation on Freezing Gait in PD

Nanjing Medical University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05174299

2021-SR-209

Details and patient eligibility

About

This study is a double-blinded randomized study examining the effectiveness of the multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord will improve FOG and gait symptoms in patients with Parkinson's disease.

Full description

Patients in the Experimental group underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on motor cortex and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one month post intervention.

Enrollment: 57 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
• 2.Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
• 3.Age between 40 and 80 years old.
• 4.Mini-Mental State Examination score >24.
• 5.Ability to walk 30 meters independently.
• 6.Stable medication.
• 7.Patients experienced FOG in both medication "on" and "off" states.

Exclusion criteria

• 1.Other neurological or psychiatric disorders.
• 2.Severe personality disorder.History of epilepsy, seizures, or convulsions.
• 3.History of head injury or stroke.
• 4.Metal remains of the skull or inside the brain (outside the oral cavity).
• 5.Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
• 6.Severe dyskinesia, termor, cognitive, visual or auditory impairment.
• 7.Patients who could not complete the follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

57 participants in 3 patient groups

double active magnetic stimulation

Experimental group

Description:

the multi-target magnetic stimulation on motor cortex combined with spinal cord

Treatment:

Device: magnetic stimulation

single active magnetic stimulation

Active Comparator group

Description:

the active magnetic stimulation on motor cortex and sham stimulation on spinal cord

Treatment:

Device: magnetic stimulation

double sham magnetic stimulation

Sham Comparator group

Description:

the sham magnetic stimulation on motor cortex and sham stimulation on spinal cord

Treatment:

Device: magnetic stimulation