Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Improvement of Depression in Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive loss of central and peripheral motor neurons. ALS leads to death usually within 3 to 5 years from the onset of the symptoms. Available treatment can prolong the disease duration but cannot modify the disease course. Depression is a frequent complication of ALS, which further decreases quality of life and the available data concerning effectivity of antidepressant drugs are conflicting. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity with confirmed antidepressive effect. The purpose of this study is to compare the effectiveness of rTMS in improving the depression in patients with ALS with placebo stimulation. Intervention will include 10 daily sessions. In each session 3000 magnetic pulses will be administered over the left dorsolateral prefrontal cortex. Assessment depression severity will be made before and after therapy, as well as two and four weeks later.
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by
progressive loss of central and peripheral motor neurons. ALS leads to death usually within 3
to 5 years from the onset of the symptoms. Available treatment can prolong the disease
duration but cannot modify the disease course. Depression is a frequent complication of ALS,
which further decreases quality of life and the available data concerning effectivity of
antidepressant drugs are conflicting. Similarly, the apathy may also complicate ALS and
worsen the prognosis. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive
method of modulation of brain plasticity with proved antidepressive effect in patients
suffering from major depression and in depression associated with several neurological
disorders such as Parkinson's disease or stroke.
The purpose of this study is to compare the effectiveness rTMS in improving the depression
and - as a secondary outcome - the apathy and daily functioning in patients with ALS.
Intervention will include ten daily sessions of rTMS. In each session 3000 magnetic pulses
will be administered over the left dorsolateral prefrontal cortex. Stimulation intensity will
equal 120% of the motor threshold value for the right first dorsal interosseus.
Assessment of depression severity and of apathy and daily functioning will be made before and
after therapy, as well as two and four weeks later.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04428775 -
A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease
|
Phase 2 | |
| Recruiting |
NCT04998305 -
TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05951556 -
Telehealth Implementation of Brain-Computer Interface
|
N/A | |
| Terminated |
NCT04579666 -
MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)
|
Phase 2 | |
| Recruiting |
NCT04082832 -
CuATSM Compared With Placebo for Treatment of ALS/MND
|
Phase 2/Phase 3 | |
| Completed |
NCT01925196 -
Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
|
||
| Completed |
NCT02496767 -
Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year
|
Phase 3 | |
| Recruiting |
NCT04816227 -
Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
|
||
| Active, not recruiting |
NCT04494256 -
A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
|
Phase 1/Phase 2 | |
| Completed |
NCT03706391 -
Study of ALS Reversals 4: LifeTime Exposures
|
||
| Recruiting |
NCT04882904 -
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
|
N/A | |
| Completed |
NCT04557410 -
Open Label Study: Treatment of ALS Fatigue With PolyMVA
|
Phase 1 | |
| Active, not recruiting |
NCT04948645 -
A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis
|
Phase 1 | |
| Not yet recruiting |
NCT04089696 -
Validation of the "ExSpiron©" in Patients With ALS
|
N/A | |
| Not yet recruiting |
NCT06450691 -
Modeling Amyotrophic Lateral Sclerosis With Fibroblasts
|
N/A | |
| Not yet recruiting |
NCT04220190 -
RAPA-501 Therapy for ALS
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05860244 -
Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients
|
Phase 2 | |
| Recruiting |
NCT02917681 -
Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03067857 -
Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02874209 -
Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis
|
N/A |