Charleston, South Carolina 29425

  • Anxiety

Purpose:

High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.


Criteria:

Inclusion Criteria: - A negative urine pregnancy test, if female subject of childbearing potential. - Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits. - After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form. Exclusion Criteria: - Clinically unstable medical disease: - cardiovascular - renal - gastrointestinal - pulmonary - metabolic - endocrine - other - CNS disease deemed progressive - Moderate or severe traumatic brain injury (TBI) - Pregnant females or those currently breast-feeding. - Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia: - vascular - Alzheimer's disease - other types - Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted. See further explanation under protection from risk. - Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial - Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation. - Currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include: - high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives. - An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant). - History of seizures or a seizure disorder.


Study is Available At:


Original ID:

00084111


NCT ID:

NCT04657432


Secondary ID:


Study Acronym:


Brief Title:

Brief, High-dose rTMS for Depression


Official Title:

Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Medical University of South Carolina


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

11


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Claire Cox, BA
(843)792-6282
coxcl@musc.edu
Backup Contact:Lisa M McTeague, PhD
(843) 792-8274
mcteague@musc.edu

Study Dates

Start Date:May 25, 2021
Completion Date:December 1, 2022
Completion Type:Anticipated
Primary Completion Date:October 14, 2022
Primary Completion Type:Anticipated
Verification Date:December 2021
Last Changed Date:December 29, 2021
First Received Date:December 1, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Depression severity (change in score)
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Depression severity as assessed by: 1. Hamilton Scale for Depression (HAM-D) Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe.
Outcome Type:Primary Outcome
Measure:Depression severity (change in score)
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Depression severity as assessed by: 2. Montgomery-Asberg Depression Rating Scale (MADRS) Rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 -
Outcome Type:Primary Outcome
Measure:Depression severity (change in score)
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Depression severity as assessed by: 3. Beck Depression Inventory-II (BDI-II) Rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 1. Inventory of Depression and Anxious Symptoms (IDAS-II) -Questions are rated on a scale from 1-5 and covers a wide array of psychological measures
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 2. Mood and Anxiety Symptom Questionnaire -Questions designed to assess symptoms of general distress using a 5-point Likert scale ranging from 1"not at all" to 5 "extremely".
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 3. Penn State Worry Questionnaire -Questions are rated on a scale from: 1-Not at all typical of me to 5-Very typical of me. Possible range of scores is 16-80 with the algorit
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 4. PTSD Checklist (PCL-5) The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: Monitoring
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 5. Life Events Checklist (LEC-5) The Life Events Checklist for DSM-5 (LEC-5) is a self-report measure designed to screen for potentially traumatic events in a respondent's lif
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 6. Childhood Trauma Questionnaire -The Childhood Trauma Questionnaire is a brief survey of six early traumatic experiences (death, divorce, violence, sexual abuse, illness or
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 7. Fagerstrom Test for Nicotine Dependence -Yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 8. Alcohol Use Disorders Identification Test (AUDIT) -The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organiza
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 9. World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) -Questions are rated on a a 5 point scale (from 0-4) Likert scale
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 10. World Health Organization Quality of Life - Brief Form (WHOQOL-BF) -Questions are rated on a a 5 point scale (from 1-5) Likert scale
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 11. Illness Intrusive Rating Scale (IIRS) -Questions are rated on a a 7 point scale (from 1-7) Likert scale which is a measure of the psychosocial impact of chronic disease
Outcome Type:Secondary Outcome
Measure:Comorbid symptom severity, functional impairment, acceptability, and tolerability
Time Frame:Day 1, post-treatment point of 1 month
Safety Issues:False
Description:Participants would complete various questionnaires (change in score assessed): 12. Quality of Life and Enjoyment and Satisfaction Questionnaire -Short Form (Q-LES-Q-SF) -Questions are rated on a 5 point scale (from 1-5) Likert scale. The minimum raw sco

Study Interventions

Intervention Type:Device
Name:Repetitive Transcranial Magnetic Stimulation (rTMS
Description:MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
Arm Name:Dose 1

Study Arms

Study Arm Type:Experimental
Arm Name:Study 2: 10 Active Doses
Description:All participants will be assigned to 10 sessions (per treatment day) of accelerated rTMS for 5 treatment days. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 50 active sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 10
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 10 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 9
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 9 is 40 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 8
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 8 is 35 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 7
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 7 is 30 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 6
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 6 is 25 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 5
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 5 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 4
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 4 is 20 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 3
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 3 is 15 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 2
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 2 is 10 sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.
Study Arm Type:Experimental
Arm Name:Dose 1
Description:All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Medical University of South Carolina
Agency Class:Other
Agency Type:Collaborator
Agency Name:National Alliance for Research on Schizophrenia & Depression

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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