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

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

Sponsors

Lead Sponsor: Jakub Antczak

Source 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.

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.

Overall Status Completed
Start Date 2017-01-09
Completion Date 2019-01-01
Primary Completion Date 2019-01-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline walking time in 10 Meter Walk Test to the measurement taken directly after rTMS Before rTMS, directly (on the same day) after rTMS
Secondary Outcome
Measure Time Frame
Timed up and go test Baseline, directly (on the same day) after rTMS and 14 days later
Medical Research Council Scale (MRC) Baseline, directly (on the same day) after rTMS and 14 days later
Modified Ashworth Scale Baseline, directly (on the same day) after rTMS and 14 days later
Change from baseline walking time in 10 Meter Walk Test to the measurement taken two weeks after rTMS Baseline, 14 days after rTMS
Enrollment 17
Condition
Intervention

Intervention Type: Device

Intervention Name: rTMS

Description: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities

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

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jakub M Antczak, MD Principal Investigator Jagiellonian University Medical College, Department of Neurology
Location
Facility: Jagiellonian University Medical College, Department of Neurology
Location Countries

Poland

Verification Date

2019-01-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Jagiellonian University

Investigator Full Name: Jakub Antczak

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: active rTMS

Type: Experimental

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.

Label: Sham rTMS

Type: Sham Comparator

Description: 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.

Study Design Info

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

Primary Purpose: Treatment

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.

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