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

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ClinicalTrials.gov Identifier: NCT03892863
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Jakub Antczak, 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: active repetitive transcranial magnetic stimulation Device: sham repetitive transcranial magnetic stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly assigned to real or placebo (sham) stimulation.
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.
Primary Purpose: Treatment
Official Title: A Pilot Study of Repetitive Transcranial Magnetic Stimulation for Improvement of Depression in Amyotrophic Lateral Sclerosis
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Active Comparator: active repetitive transcranial magnetic stimulation
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: active repetitive transcranial magnetic stimulation
High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex

Sham Comparator: sham repetitive transcranial magnetic stimulation
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: sham repetitive transcranial magnetic stimulation
High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex




Primary Outcome Measures :
  1. Beck's Depression Inventory ater rTMS, total score, range 0 to 63, with higher values representing a worse outcome [ Time Frame: Before rTMS, directly (on the same day) after finishing rTMS ]
    Change from baseline score in the Beck's Depression Inventory to the measurement taken directly after finishing rTMS.

  2. Beck's Depression Inventory first follow up, total score, range 0 to 63, with higher values representing a worse outcome [ Time Frame: Before rTMS, two weeks after finishing rTMS ]
    Change from baseline score in the Beck's Depression Inventory to the measurement taken two weeks after finishing rTMS.

  3. Beck's Depression Inventory second follow up, total score, range 0 to 63, with higher values representing a worse outcome [ Time Frame: Before rTMS, four weeks after finishing rTMS ]
    Change from baseline score in the Beck's Depression Inventory to the measurement taken four weeks after finishing rTMS.


Secondary Outcome Measures :
  1. Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised after rTMS, total score, range 0 to 40 with higher values representing a better outcome [ Time Frame: Before rTMS, directly (on the same day) after finishing rTMS ]
    Change from baseline score in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken directly after finishing rTMS.

  2. Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised first follow up, total score, range 0 to 40 with higher values representing a better outcome [ Time Frame: Before rTMS, two weeks after finishing rTMS ]
    Change from baseline score in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken two weeks after finishing rTMS.

  3. Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised second follow up, total score, range 0 to 40 with higher values representing a better outcome [ Time Frame: Before rTMS, four weeks after finishing rTMS ]
    Change from baseline score in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised to the measurement taken directly after finishing rTMS.

  4. Apathy Evaluation Scale Clinical Version ater rTMS, total score, range 18 to 72 with higher values representing a worse outcome [ Time Frame: Before rTMS, directly (on the same day) after finishing rTMS ]
    Change from baseline score in the Apathy Evaluation Scale Clinical Version to the measurement taken taken directly after finishing rTMS.

  5. Apathy Evaluation Scale Clinical Version first follow up, total score, range 18 to 72 with higher values representing a worse outcome [ Time Frame: Before rTMS, two weeks after finishing rTMS ]
    Change from baseline score in the Apathy Evaluation Scale Clinical Version to the measurement taken two weeks after finishing rTMS.

  6. AES-C second follow up, total score, range 18 to 72 with higher values representing a worse outcome [ Time Frame: Before rTMS, four weeks after finishing rTMS ]
    Change from baseline score in the Apathy Evaluation Scale Clinical Version to the measurement taken four weeks after finishing rTMS.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892863


Contacts
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Contact: Jakub M Antczak, MD +48 795 421 153 jantczak@cm-uj.krakow.pl
Contact: Magdalena Spaczyńska-Boczar, MD +48 12 424 86 00 magda.spaczynska@gmail.com

Locations
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Poland
Jagiellonian University Medical College, Department of Neurology Not yet recruiting
Kraków, Poland, 31503
Contact: Jakub M Antczak, MD    +48 795 421 153    jantczak@cm-uj.krakow.pl   
Sub-Investigator: Magsalena Spaczyńska-Boczar, MD         
Sponsors and Collaborators
Jagiellonian University
Investigators
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Principal Investigator: Jakub M Antczak, MD Department of Neurology, Jagiellonian University Medical College

Publications:

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Responsible Party: Jakub Antczak, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03892863     History of Changes
Other Study ID Numbers: JagiellonianU61
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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, Beck depression inventory, AES-C and Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised will be made available to other researchers on request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The data will become available after the study is published.
Access Criteria: On request send by e-mail: jantczak@cm-uj.krakow.pl

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jakub Antczak, Jagiellonian University:
Amyotrophic Lateral Sclerosis
depression
rTMS

Additional relevant MeSH terms:
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Depression
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Behavioral Symptoms
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases