Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy

Related Clinical Trial
Modeling Macrophages Activation Pattern in X-linked Adrenoleukodystrophy and Metachromatic Leukodystrophy SMART-ALD – A New Lifestyle Intervention to Improve Quality of Life in Women With X-linked Adrenoleukodystrophy (X-ALD) Quality of Life in Women With X-linked Adrenoleukodystrophy A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT) Plasma Exchange With Albumin in AMN Patients Stem Cell Transplant for Inborn Errors of Metabolism Human Placental-Derived Stem Cell Transplantation Precision Exercise in Children With Malignant Hemopathies Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy Effect of Pioglitazone Administered to Patients With Adrenomyeloneuropathy MD1003-AMN MD1003 in Adrenomyeloneuropathy A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients. Observational Study to Evaluate Allogeneic HSCT Outcomes for Cerebral Adrenoleukodystrophy (CALD) A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants Autologous Hematopoietic Stem Cell Gene Therapy for Metachromatic Leukodystrophy and Adrenoleukodystrophy Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy Clinical Study and Gene Mutation Analysis of Adrenoleukodystrophy in Taiwanese Children Early Diagnosis Of Childhood Cerebral ALD Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy Multi-center Clinical Study on the Diagnosis and Treatment Management of Rare Neurological Disease in Children HSCT for High Risk Inherited Inborn Errors Longitudinal Natural History Study of Patients With Peroxisome Biogenesis Disorders (PBD) UCB Transplant of Inherited Metabolic Diseases With Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HaploHCT) Following Reduced Intensity Conditioning (RIC) for Selected High Risk Non-Malignant Diseases The Effect of Bezafibrate on the Level of Very Long Chain Fatty Acids (VLCFA) in X-linked Adrenoleukodystrophy (X-ALD) A Phase III Trial of Lorenzo’s Oil in Adrenomyeloneuropathy Lentiviral Gene Therapy for X-ALD MT2014-14 IT-MSC for Advanced Cerebral Adrenoleukodystrophy (cALD) Safety and Pharmacodynamic Study of Sobetirome in X-Linked Adrenoleukodystrophy (X-ALD) Newborn Screening for Adrenoleukodystrophy A Study to Prospectively Assess Disease Progression in Male Children With X-ALD Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product Exercise Study of Function and Pathology for Women With X-linked Adrenoleukodystrophy Expanded Access for Lorenzo’s Oil (GTO/GTE) in Adrenoleukodystrophy Minnesota Adrenoleukodystrophy Registry Study (MARS) and Biobank A Pilot Study of Vitamin D in Boys With X-linked Adrenoleukodystrophy Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy

Brief Title

Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy

Official Title

A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Improvement of Gait in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy

Brief 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.
    


Study Type

Interventional


Primary Outcome

Change from baseline walking time in 10 Meter Walk Test to the measurement taken directly after rTMS

Secondary Outcome

 Timed up and go test

Condition

Hereditary Spastic Paraplegia

Intervention

rTMS

Study Arms / Comparison Groups

 active rTMS
Description:  10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

17

Start Date

January 9, 2017

Completion Date

January 1, 2019

Primary Completion Date

January 1, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  diagnosis of hereditary spastic paraplegia - confirmed genetically, on the basis of
             family history or on exclusion or diagnosis of adrenomyeloneuropathy - confirmed
             genetically or by the elevated plasma very long chain fatty acid or on family history

          -  Gait disturbances affecting daily activities

          -  Ability to walk 10 meters without assistance or with crutches or with rollator walker

        Exclusion Criteria:

          -  Presence of signs or symptoms indicating other than HSP or AMN ethiology of gait
             disturbances

          -  Contraindications for rTMS as listed by the Guidelines of the International Federation
             of Clinical Neurophysiology (IFCN 2009) i.e. seizure in the past, epilepsy, presence
             of magnetic material in the reach of magnetic field, pregnancy, likelihood to get
             pregnant, intracranial electrodes, cardiac pacemaker or intracardiac lines, frequent
             syncopes
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jakub M Antczak, MD, , 

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT03627416

Organization ID

JagiellonianU59


Responsible Party

Sponsor-Investigator

Study Sponsor

Jakub Antczak


Study Sponsor

Jakub M Antczak, MD, Principal Investigator, Jagiellonian University Medical College, Department of Neurology


Verification Date

January 2019