Efficacy of Repetitive Trans-spinal Magnetic Stimulation on Axial Motor Symptoms in PD
Condition: Adverse Effect of Drug Therapy Levodopa
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Interventional

Summary: 
      The purpose of this randomized trial was to evaluate the efficacy of repeated sessions of
      trans-spinal magnetic stimulation on gait abnormality, and posture abnormalities in patients
      with idiopathic Parkinson's disease.
    

Detailed description: 
      Parkinson's disease is the second most common age-related neurodegenerative disease after
      Alzheimer's disease[1], patients with advanced Parkinson's disease (PD) often present with
      axial symptoms, including abnormal posture, postural instability, and gait disorder [2].
      These axial symptoms are the main factors that reduce the activities of daily living (ADL)
      and quality of life (QOL) of PD patients. Gait disorders are among the most prevalent
      problems in the advanced phase of Parkinson's disease (PD) and are relatively resistant to
      dopaminergic treatment. Freezing of gait (FoG) affects 7% of patients in early PD and reaches
      60% in advanced stages [3]. Patients with PD also suffer from pain significantly more
      frequently than normal subjects. Low back pain and leg pain are the most commonly experienced
      pain symptoms in PD patients. One of the reasons is considered to be the decreased threshold
      of pain due to abnormality of the dopaminergic system in the basal ganglia of PD patients
      [3.4]. Administration of anti-parkinsonian medication or Deep brain stimulation results in
      increased pain thresholds. Treatment by medication or DBS is often ineffective for low back
      pain caused by postural deformity and is also ineffective for radicular or peripheral
      neuropathic. Because pain is an important factor that reduces the ADL and QOL of patients,
      the establishment of new and effective therapy is essential [5.6]. A positive effect of
      epidural spinal cord stimulation (SCS) on locomotive activity has been reported in animal
      models and small cohorts of PD patients and seems to be promising.[7] Transcutaneous SCS is
      an emerging method that activates similar target neural structures noninvasively and has
      recently been explored for the treatment of spasticity after spinal cord injury.[8] Here, the
      investigators will assess the safety and efficacy of transcutaneous magnetic SCS on freezing
      of gait (FoG) and other motor symptoms in a cohort of PD patients.

      The investigators will be going to carry out a double-blinded randomized, case-controlled
      study on 42 patients who will be randomly chosen and categorize them into 2 groups, 21
      patients each. The 1st group will receive real transcranial magnetic stimulation applied over
      each hand area High frequency 20 HZ, 80% of the motor threshold of hand, 10 sec for each
      train, 20 train with a total of 2000 pulses for each side plus transcutaneous spinal cord
      stimulation (over mid-dorsal vertebrae (thoracic 6) high frequency 10 HZ, 80% of the motor
      threshold of leg area10 sec for each train, 10 trains with total 1000 pulses for 10
      consecutive days. The second group will receive the same protocol but the spinal stimulation
      will be sham stimulation as the coil lie perpendicular to the vertebral axis. Then the
      investigators will be going to compare the results of two groups at the end of sessions, one
      and two months after the last session to find out the efficacy of repetitive transcutaneous
      magnetic stimulation of the spinal cord on gait abnormalities and posture abnormalities,
      relief of pain, UPDRS, and as well as the quality of life in patients with idiopathic
      Parkinson's disease
    

Intervention name(s): non invasive repetitive magnetic stimulation (real Transcranial + real trans-spinal ); non invasive repetitive magnetic stimulation (real Transcranial + sham trans-spinal )sham trans-spinal magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): repetitive transcranial magnetic stimulation and trans-spinal magnetic stimulation; sham trans-spinal magnetic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; Parkinson's disease; therapeutic role; spinal magnetic stimulation; gait disturbance, frozen gait; UPDRS, Quality of life, Visual analogue scale