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

NCT03627416 | Completed Results

• 1 other identifier: JagiellonianU59
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Spastic Paraplegia; Adrenomyeloneuropathy

Keywords

Hereditary spastic paraplegia; repetitive transcranial magnetic stimulation; disturbed gait; Adrenomyeloneuropthy

Outcome Measures

Primary Outcomes (1)

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

  Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and directly after rTMS.

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

Secondary Outcomes (4)

• Change in Timed up and go Test

  Baseline, directly (on the same day) after rTMS and 14 days later

• Change in 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

Study Arms (2)

active rTMS

EXPERIMENTAL

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

Sham rTMS

SHAM COMPARATOR

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

Interventions

rTMS DEVICE

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

Sham rTMS; active rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gait disturbances affecting daily activities
• Ability to walk 10 meters without assistance or with crutches or with rollator walker

You may not qualify if:

• 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

Sponsors & Collaborators

• Jakub Antczak: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Neurology

Krakow, 31503, Poland

Location

Related Publications (2)

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 RESULT

• Antczak J, Pera J, Dabros M, Kozminski W, Czyzycki M, Wezyk K, Dwojak M, Banach M, Slowik A. The Effect of Repetitive Transcranial Magnetic Stimulation on Motor Symptoms in Hereditary Spastic Paraplegia. Neural Plast. 2019 May 12;2019:7638675. doi: 10.1155/2019/7638675. eCollection 2019.

  PMID: 31214256 DERIVED

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary; Adrenoleukodystrophy

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and 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; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Genetic Diseases, X-Linked; Metabolism, Inborn Errors; Peroxisomal Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases

Limitations and Caveats

Limited number of sessions, which may decrease the magnitude of the therapeutic effect. The abundant pharmacotherapy with baclofen could considerably reduce observed effects on spasticity.

Results Point of Contact

• Title: Dr. Jakub Antczak
• Organization: Jagiellonian University Medical College

jantczak@uj.edu.pl

+48 795 421 153

Study Officials

• Jakub M Antczak, MD

  Jagiellonian University Medical College, Department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 16 patients with HSP or AMN will receive either active and sham stimulation in random order

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: August 13, 2018
• Study Start: January 9, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 27, 2021
• Results First Posted: September 27, 2021

Record last verified: 2021-08

Locations

PL (1)