N/A
N=15
Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy
Hereditary Spastic Paraplegia · Adrenomyeloneuropathy
Bottom Line
View on ClinicalTrials.gov: NCT03627416 ↗Enrolled (actual)
15
Serious AEs
3.3%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Directly After rTMS — -5.41; 1.70 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jakub Antczak
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Directly After rTMS |
-5.41; 1.70 | — |
| SECONDARY Change in Timed up and go Test |
-4.72; 0.18; -2.92; 0.78 | — |
| SECONDARY Change in Medical Research Council Scale (MRC) |
0; 0.06; 0.09; 0 | — |
| SECONDARY Modified Ashworth Scale |
-0.36; 0; -0.27; -0.11 | — |
| SECONDARY Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Two Weeks After rTMS |
-5.84; 0.93 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03627416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.