Repetitive Transcranial Magnetic Stimulation as Therapy for Depression in Amyotrophic Lateral Sclerosis

A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Improvement of Depression in Amyotrophic Lateral Sclerosis

Sponsors

Lead Sponsor: Jagiellonian University

Source Jagiellonian University
Brief Summary

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.

Detailed Description

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.

Overall Status Withdrawn
Start Date 2019-11-15
Completion Date 2021-12-31
Primary Completion Date 2021-06-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Beck's Depression Inventory ater rTMS, total score, range 0 to 63, with higher values representing a worse outcome 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 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 Before rTMS, four weeks after finishing rTMS
Secondary Outcome
Measure Time Frame
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised after rTMS, total score, range 0 to 40 with higher values representing a better outcome 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 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 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 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 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 Before rTMS, four weeks after finishing rTMS
Condition
Intervention

Intervention Type: Device

Intervention Name: active repetitive transcranial magnetic stimulation

Description: High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex

Arm Group Label: active repetitive transcranial magnetic stimulation

Intervention Type: Device

Intervention Name: sham repetitive transcranial magnetic stimulation

Description: High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex

Arm Group Label: sham repetitive transcranial magnetic stimulation

Eligibility

Criteria:

Inclusion Criteria: - Diagnosis of definite or probable ALS according to el Escorial criteria (Brooks et al. 2000) - Depression defined as the score in Beck's Depression Inventory ≥14 - Mini-Mental State Examination score ≥26 Exclusion Criteria: - Psychiatric symptoms, which may negatively influence patient's tolerance and adherence to therapy - Respiratory insufficiency and other complications od advanced stages of ALS, which may compromise patient's ability to undergo the study procedure - Contraindications for rTMS as listed by the Guidelines of the International Federation of Clinical Neurophysiology (Rossi et al. 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 Department of Neurology, Jagiellonian University Medical College
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Jagiellonian University Medical College, Department of Neurology
Location Countries

Poland

Verification Date

2020-02-01

Responsible Party

Type: Principal 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 repetitive transcranial magnetic stimulation

Type: Active Comparator

Description: 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.

Label: sham repetitive transcranial magnetic stimulation

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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Patients will be randomly assigned to real or placebo (sham) stimulation.

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, 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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