Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy
Condition: Hereditary Spastic Paraplegia; Adrenomyeloneuropathy
MeSH terms: Muscle Spasticity; Paraplegia; Spastic Paraplegia, Hereditary; Adrenoleukodystrophy
Study type: Interventional

Summary: 
      Hereditary spastic paraplegia (HSP) is the group of inherited disorders, characterized by
      progressive gait disturbance. There is no established therapy. Adrenoleukodystrophy (AMN) is
      an x-linked hereditary disease. One of its form, the adrenomyeloneuropathy has the same
      symptoms as HSP. Current therapeutic options for AMN are very limited. Repetitive
      Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain
      plasticity. The purpose of this study is to compare the effectiveness of rTMS in improving
      the HSP- and AMN-related gait disturbance and other symptoms with sham stimulation.

      Intervention will include five daily sessions. In each session 1500 magnetic pulses will be
      administered to each of both primary motor areas for lower extremities. Assessment of gait
      and of strength and spasticity of lower extremities will be made before and after therapy, as
      well as two weeks later.
    

Detailed description: 
      Hereditary spastic paraplegia (HSP) is a group of inherited disorders, characterized by
      progressive gait disturbance with weakness and spasticity, which predominate in lower
      extremities. There is no established therapy. Adrenoleukodystrophy (AMN) is an x-linked
      hereditary disease. One of its form, the adrenomyeloneuropathy has the same symptoms as HSP.
      Current therapeutic options for AMN are very limited. Repetitive Transcranial Magnetic
      Stimulation (rTMS), a noninvasive method of modulation of brain plasticity proved to be
      effective in improving the gait performance in several conditions such as Parkinson Disease,
      vascular Parkinsonism, partial spinal cord injury and in post-stroke paresis. Previous
      studies documented also altered cortical excitability in HSP patients.

      The purpose of this study is to compare the effectiveness of 10 hertz (Hz) rTMS over the
      primary motor cortices in improving the gait and strength and spasticity of lower extremities
      with sham stimulation in HSP and AMN patients.

      Intervention will include five daily sessions. In each session 1500 magnetic pulses will be
      administered to each of both primary motor areas for lower extremities. Assessment of gait
      and of strength and spasticity of lower extremities will be made before and after therapy, as
      well as two weeks later.
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 16 patients with HSP or AMN will receive either active and sham stimulation in random order
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hereditary spastic paraplegia; repetitive transcranial magnetic stimulation; disturbed gait; Adrenomyeloneuropthy