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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex
High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex
Jagiellonian University Medical College, Department of Neurology
Krakow, Poland
Beck's Depression Inventory ater rTMS, total score, range 0 to 63, with higher values representing a worse outcome
Change from baseline score in the Beck's Depression Inventory to the measurement taken directly after finishing rTMS.
Time frame: Before rTMS, directly (on the same day) after finishing rTMS
Beck's Depression Inventory first follow up, total score, range 0 to 63, with higher values representing a worse outcome
Change from baseline score in the Beck's Depression Inventory to the measurement taken two weeks after finishing rTMS.
Time frame: Before rTMS, two weeks after finishing rTMS
Beck's Depression Inventory second follow up, total score, range 0 to 63, with higher values representing a worse outcome
Change from baseline score in the Beck's Depression Inventory to the measurement taken four weeks after finishing rTMS.
Time frame: Before rTMS, four weeks after finishing rTMS
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised after rTMS, total score, range 0 to 40 with higher values representing a better outcome
Change from baseline score in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken directly after finishing rTMS.
Time frame: Before rTMS, directly (on the same day) after finishing rTMS
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised first follow up, total score, range 0 to 40 with higher values representing a better outcome
Change from baseline score in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken two weeks after finishing rTMS.
Time frame: Before rTMS, two weeks after finishing rTMS
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised second follow up, total score, range 0 to 40 with higher values representing a better outcome
Change from baseline score in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken directly after finishing rTMS.
Time frame: Before rTMS, four weeks after finishing rTMS
Apathy Evaluation Scale Clinical Version ater rTMS, total score, range 18 to 72 with higher values representing a worse outcome
Change from baseline score in the Apathy Evaluation Scale Clinical Version to the measurement taken taken directly after finishing rTMS.
Time frame: Before rTMS, directly (on the same day) after finishing rTMS
Apathy Evaluation Scale Clinical Version first follow up, total score, range 18 to 72 with higher values representing a worse outcome
Change from baseline score in the Apathy Evaluation Scale Clinical Version to the measurement taken two weeks after finishing rTMS.
Time frame: Before rTMS, two weeks after finishing rTMS
AES-C second follow up, total score, range 18 to 72 with higher values representing a worse outcome
Change from baseline score in the Apathy Evaluation Scale Clinical Version to the measurement taken four weeks after finishing rTMS.
Time frame: Before rTMS, four weeks after finishing rTMS
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