An interventional study of rTMS in Amyotrophic Lateral Sclerosis, sponsored by Jagiellonian University. Withdrawn at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Jagiellonian University · Not applicable, Interventional, and Treatment
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. Apathy is a frequent complication of ALS, affecting up to 30% of patients and affecting negatively the survival. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity with confirmed beneficial effect on apathy in several neurologic and psychiatric conditions. The purpose of this study is to compare the effectiveness of rTMS in improving the apathy in patients with ALS with placebo stimulation.
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. Apathy is a frequent complication of ALS, which negatively influences quality of life (caga et al. 2018) and is an independent poor prognostic factor for survival (Caga et al. 2016). Similarly, the depression is also a frequent complication of ALS. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity with confirmed beneficial effect on apathy in several neurologic and psychiatric conditions like mild cognitive impairment (Padala et al. 2018), stroke (Sasaki et al. 2017), Alzheimer disease (Nguyen et al. 2017) and schizophrenia (Prikryl et al. 2013). The purpose of this study is to compare the effectiveness of rTMS in improving the apathy in patients with ALS with placebo stimulation and - as a secondary outcome - depression 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 apathy and of depression and daily functioning will be made before and after therapy, as well as two and four weeks later.
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10 hertz (Hz) rTMS will be administered over the left dorsolateral prefrontal cortex. Therapy will include 10 daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 120% of the resting motor threshold intensity will be elicited.
Device: rTMS
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
High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex.
Apathy Evaluation Scale Clinical Version after rTMS, total score, range 18 to 72 with higher values representing a worse outcome
Change from baseline score in Apathy Evaluation Scale Clinical Version to the measurement taken directly after finishing rTMS.
Time frame: Baseline rTMS, directly (on the same 1 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 Apathy Evaluation Scale Clinical Version to the measurement taken two weeks after finishing rTMS.
Time frame: Baseline rTMS, two weeks after finishing rTMS
Apathy Evaluation Scale Clinical Version second follow up, total score, range 18 to 72 with higher values representing a worse outcome
Change from baseline score in Apathy Evaluation Scale Clinical Version to the measurement taken four weeks after finishing rTMS
Time frame: Baseline rTMS, four weeks after finishing rTMS
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 Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken directly after finishing rTMS.
Time frame: Baseline rTMS, directly (on the same 1 day) after finishing rTMS
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: Baseline rTMS, two weeks after finishing rTMS
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 Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken directly after finishing rTMS
Time frame: Baseline rTMS, four weeks after finishing rTMS
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: Baseline rTMS, directly (on the same 1 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: Baseline 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: Baseline rTMS, four weeks after finishing rTMS
Plan to share: Yes — After completing the study, the details of neurophysiologic diagnostics including motor threshold, the age and gender as well as individual scores of Mini-Mental State Examination, AES-C, Beck's Depression Inventory and Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised will be made available to other researchers on request.
Supporting information: Study protocol, Sap, Icf
This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Jagiellonian University