Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03627416 |
|
Recruitment Status :
Completed
First Posted : August 13, 2018
Results First Posted : September 27, 2021
Last Update Posted : September 27, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 (Clinical Trial) |
| Actual Enrollment : | 15 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 |
- 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 ]Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and directly after rTMS.
- Change in 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.
- Change in Medical Research Council Scale (MRC) [ Time Frame: Baseline, directly (on the same day) after rTMS and 14 days later ]Change in 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, with higher values representing stronger movements, which is better outcome. Values are averaged from all movements tested.
- 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, with higher values representing more severe spasticity, which is worse outcome. Values are averaged from all movements tested.
- 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 ]Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and 14 days after finishing rTMS therapy.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Poland | |
| Jagiellonian University Medical College, Department of Neurology | |
| Kraków, Poland, 31503 | |
| Principal Investigator: | Jakub M Antczak, MD | Jagiellonian University Medical College, Department of Neurology |
Documents provided by Jakub Antczak, Jagiellonian University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jakub Antczak, Principal Investigator, Jagiellonian University |
| ClinicalTrials.gov Identifier: | NCT03627416 |
| Other Study ID Numbers: |
JagiellonianU59 |
| First Posted: | August 13, 2018 Key Record Dates |
| Results First Posted: | September 27, 2021 |
| Last Update Posted: | September 27, 2021 |
| Last Verified: | August 2021 |
| 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 |
|
Hereditary spastic paraplegia repetitive transcranial magnetic stimulation disturbed gait Adrenomyeloneuropthy |
|
Adrenoleukodystrophy Muscle Spasticity Paraplegia Spastic Paraplegia, Hereditary Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases 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 Neurobehavioral Manifestations |