CompletedNot Applicable

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

Poland15 participantsStarted 2017-01-09

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Directly After rTMS

Timeframe: Before rTMS, directly (on the same day) after rTMS

Trial details

NCT IDNCT03627416

SponsorJakub Antczak

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-01

Results submitted2021-02-09