Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 677 for:    amyotrophic lateral sclerosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03892382
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : August 8, 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. 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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: rTMS 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. 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.


Layout table for study information
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 Apathy in Amyotrophic Lateral Sclerosis
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Active Comparator: Active rTMS
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
High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex.

Sham Comparator: Sham 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.




Primary Outcome Measures :
  1. Apathy Evaluation Scale Clinical Version after rTMS, total score, range 18 to 72 with higher values representing a worse outcome [ Time Frame: Baseline rTMS, directly (on the same 1 day) after finishing rTMS ]
    Change from baseline score in Apathy Evaluation Scale Clinical Version to the measurement taken directly after finishing rTMS.

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

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


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

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

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

  5. Beck's Depression Inventory first follow up, total score, range 0 to 63, with higher values representing a worse outcome [ Time Frame: Baseline 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.

  6. Beck's Depression Inventory second follow up, total score, range 0 to 63, with higher values representing a worse outcome [ Time Frame: Baseline 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)
  • Moderate or severe depression defined as the score in Beck's Depression Inventory ≥20
  • 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): NCT03892382


Contacts
Layout table for location contacts
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
Layout table for location information
Poland
Jagiellonian University Medical College, Department of Neurology
Kraków, Poland, 31503
Sponsors and Collaborators
Jagiellonian University
Investigators
Layout table for investigator information
Principal Investigator: Jakub M Antczak, MD Department of Neurology, Jagiellonian University Medical College

Publications:

Layout table for additonal information
Responsible Party: Jakub Antczak, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03892382     History of Changes
Other Study ID Numbers: JagiellonianU62
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 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, AES-C, Beck's Depression Inventory 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

Layout table for additional information
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
rTMS
apathy
depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases