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Spectral Correlation Coefficient-based TMS

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04040062
Recruitment Status : Enrolling by invitation
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew F. Leuchter, University of California, Los Angeles

Brief Summary:
This study will analyze the feasibility, safety, and tolerability of administering repetitive Transcranial magnetic stimulation(TMS) at frequencies other than standard 10 Hz. This study will enroll 10 subjects who will undergo one quantitative electroencephalograph, one TMS procedure to determine the appropriate frequency and intensity for treatment, weekly mood/symptom assessments, and up to 30 TMS treatments. Subjects will be asked to participate for up to 6 weeks.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial Magnetic Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: We will identify the participant's individual spectral correlation coefficient (SCC) by stimulation with 68 different stimulation pulse trains of 40 pulses each at frequencies ranging between 3 and 20 Hz in steps of 0.25 Hz, plus intermittent theta burst (iTBS) stimulation, in randomized order. We will then select the frequency with the largest connectivity density (strong and focal connectivity increase within the fronto-parietal control network) in the range of 3 and 20 Hz as the optimal individual stimulation density and treat the participants at this optimal Hz for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Evaluating the Feasibility of Repetitive Transcranial Magnetic Stimulation Treatment Delivered at Individual-based, SCC-determined Frequency in Subjects Suffering From Major Depressive Disorder
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SCC
Subjects will be treated according to their frequency response pattern which may show one or more distinct frequencies of stimulation that generated increased SCC
Device: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. Using pulsed magnetic fields, transcranial magnetic stimulation therapy stimulates the part of the brain thought to be involved with mood regulation. These magnetic fields do not directly affect the whole brain; they only reach about 2-3 centimeters into the brain directly beneath the treatment coil.As these magnetic fields move into the brain, they produce very small electrical currents. These electrical currents activate cells within the brain, causing them to rewire, a process called neuroplasticity.




Primary Outcome Measures :
  1. Inventory of Depressive Symptoms- Self report [ Time Frame: Weekly ]
    This survey is designed to assess the severity of depressive symptoms. The IDS assess all the criterion symptom domains designated by the American PsychiatryAssociation Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) (APA1994) to diagnose a major depressive episode. These assessments can be used to screen fordepression, although they have been used predominantly as measures of symptom severity. The seven day period prior to assessment is the usual time frame for assessing symptom severity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects must be over between 18-65 years of age.
  • Must have confirmed diagnosis of severe Major Depressive Disorder (single or recurrent episode).
  • Failure to respond to a minimum of 4 trials of antidepressant medication
  • Failure to respond from at least two different agent classes
  • Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count).
  • Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration.
  • Subjects are willing and able to adhere to the treatment schedule and required study visits

Exclusion Criteria:

  • Are mentally or legally incapacitated, unable to give informed consent
  • Have an infection or poor skin condition over the scalp where the device will be positioned
  • Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
  • Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
  • Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
  • Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 centimeters from the transcranial magnetic stimulation magnetic coil or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.

(Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation


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): NCT04040062


Locations
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United States, California
University of California
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles

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Responsible Party: Andrew F. Leuchter, Director of UCLA Neuromodulation, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04040062    
Other Study ID Numbers: 19-005605
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms