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Repetitive Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation for Depression and Anxiety

N/A
Recruiting
Led By Desmond Oathes, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18-65 years old
Be older than 18 years old
Must not have
History of neurological disorder or traumatic brain injury (other than mild)
Unable to receive or tolerate Transcranial Magnetic Stimulation (TMS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Summary

This trial will use fMRI and muscle activity data to determine negative affect maps for each participant. They will then try a variety of patterned repetitive transcranial magnetic stimulation sequences while recording fMRI which will be the basis of two sessions of 3-day individualized brain stimulation designed to reduce negative affect.

Who is the study for?
This trial is for adults aged 18-65 with moderate to severe depression or anxiety, as indicated by a PHQ-9 score of 10 or higher. Participants must be right-handed, understand English instructions, and can consent and commit to the study duration. Exclusions include bipolar disorder, psychotic disorders, recent psychoactive substance use, neurological issues preventing MRI scans or TMS treatment.Check my eligibility
What is being tested?
The trial tests personalized brain stimulation using Transcranial Magnetic Stimulation (TMS) to reduce negative emotions in individuals with depression and anxiety. It involves creating unique emotional brain maps via fMRI and muscle activity data then applying tailored TMS sequences over six sessions across three days.See study design
What are the potential side effects?
Potential side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, tingling sensations on the scalp or face during treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of a serious neurological disorder or traumatic brain injury.
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I cannot undergo or tolerate Transcranial Magnetic Stimulation.
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I have a history of stroke, epilepsy, or brain scarring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ruminative response scale (RRS) score after using the optimal rTMS stimulation frequency vs the least optimal rTMS stimulation frequency

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Neuromodulation using the optimal rTMS stimulation frequencyExperimental Treatment1 Intervention
Through manipulation of brain state with a negative-affect task and using fMRI as the feedback signal, we aim to fine-tune repetitive Transcranial Magnetic Stimulation (rTMS) delivery to maximally impact the desired brain states in awake behaving study participants in a highly individualized manner (Visit 3: TMS/fMRI). The optimal rTMS stimulation frequency will be tested in a 3-day rTMS neuromodulation intervention.
Group II: Neuromodulation using the least optimal rTMS stimulation frequencyActive Control1 Intervention
We will compare the results of the optimal rTMS frequency neuromodulation with a separate 3-day neuromodulation session using the least optimal rTMS frequency, as determined by Visit 3: TMS/fMRI.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include pharmacotherapy, psychotherapy, and neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS). Pharmacotherapy typically involves antidepressants that modulate neurotransmitters such as serotonin, norepinephrine, and dopamine to improve mood and emotional regulation. Psychotherapy, including cognitive-behavioral therapy (CBT), helps patients reframe negative thought patterns and develop coping strategies. Neuromodulation techniques like rTMS use magnetic fields to stimulate specific brain regions involved in mood regulation, potentially disrupting negative emotion patterns. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage expectations regarding efficacy and side effects.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,027 Previous Clinical Trials
42,885,671 Total Patients Enrolled
69 Trials studying Depression
29,408 Patients Enrolled for Depression
Desmond Oathes, PhDPrincipal InvestigatorAssistant Professor of Psychiatry
1 Previous Clinical Trials
41 Total Patients Enrolled

Media Library

Transcranial Magnetic Stimulation (Repetitive Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05437705 — N/A
Depression Research Study Groups: Neuromodulation using the optimal rTMS stimulation frequency, Neuromodulation using the least optimal rTMS stimulation frequency
Depression Clinical Trial 2023: Transcranial Magnetic Stimulation Highlights & Side Effects. Trial Name: NCT05437705 — N/A
Transcranial Magnetic Stimulation (Repetitive Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05437705 — N/A
~27 spots leftby Dec 2027