Brief, High-dose rTMS for Depression

Medical University of South Carolina (MUSC)

Status: Active, not recruiting

Conditions: Depression; Anxiety

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04657432

00084111

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 11 patient groups

Dose 1

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 2

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 3

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 4

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 5

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 6

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 7

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 8

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 9

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Dose 10

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study 2: 10 Active Doses

Experimental group

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)