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

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ClinicalTrials.gov Identifier: NCT03627416
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jakub Antczak, Jagiellonian University

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.


Condition or disease Intervention/treatment Phase
Hereditary Spastic Paraplegia Adrenomyeloneuropathy Device: rTMS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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)
Masking Description: Sham stimulation will be provided by holding the stimulating coil perpendicularly to the scalp, which assures similar impression as during active stimulation but prevents significant magnetic field to reach the brain tissue.
Primary Purpose: Treatment
Official Title: A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Improvement of Gait in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy
Actual Study Start Date : January 9, 2017
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019


Arm Intervention/treatment
Experimental: active rTMS
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.
Device: rTMS
high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities

Sham Comparator: Sham rTMS
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
Device: rTMS
high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities




Primary Outcome Measures :
  1. Change from baseline walking time in 10 Meter Walk Test to the measurement taken directly after rTMS [ Time Frame: Before rTMS, directly (on the same day) after rTMS ]
    Time of walking barefoot the distance of 10 meters


Secondary Outcome Measures :
  1. Timed up and go test [ Time Frame: Baseline, directly (on the same day) after rTMS and 14 days later ]
    Time of standing up from a chair, walking three metres to cross a line drawn 3 meters ahead and going back to sit down on the chair.

  2. Medical Research Council Scale (MRC) [ Time Frame: Baseline, directly (on the same day) after rTMS and 14 days later ]
    Bilateral assessment of the strength of following movements: hip flexion, knee flexion and extension, ankle flexion and extension. Assessment will be made according to six degrees (0 to 5) MRC scale

  3. Modified Ashworth Scale [ Time Frame: Baseline, directly (on the same day) after rTMS and 14 days later ]
    Bilateral assessment of spasticity in following movements: hip flexion, knee flexion and extension, ankle flexion and extension. Assessment will be made according to six degrees (0 to 5) Modified Ashworth Scale

  4. Change from baseline walking time in 10 Meter Walk Test to the measurement taken two weeks after rTMS [ Time Frame: Baseline, 14 days after rTMS ]
    Time of walking barefoot the distance of 10 meters



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627416


Locations
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Poland
Jagiellonian University Medical College, Department of Neurology
Kraków, Poland, 31503
Sponsors and Collaborators
Jakub Antczak
Investigators
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Principal Investigator: Jakub M Antczak, MD Jagiellonian University Medical College, Department of Neurology

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jakub Antczak, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03627416     History of Changes
Other Study ID Numbers: JagiellonianU59
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jakub Antczak, Jagiellonian University:
Hereditary spastic paraplegia
repetitive transcranial magnetic stimulation
disturbed gait
Adrenomyeloneuropthy

Additional relevant MeSH terms:
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Muscle Spasticity
Paraplegia
Spastic Paraplegia, Hereditary
Adrenoleukodystrophy
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paralysis
Hereditary Sensory and Motor Neuropathy
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Hereditary Central Nervous System Demyelinating Diseases
Leukoencephalopathies
Demyelinating Diseases
Mental Retardation, X-Linked
Intellectual Disability