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Procedure

rTMS for Neurological Symptoms (SET Trial)

N/A
Recruiting
Research Sponsored by Neuronetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults, 22 to 70 years of age
Be older than 18 years old
Must not have
History of head trauma associated with loss of consciousness or diagnosed as concussion.
Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the symptoms that occur after repetitive transcranial magnetic stimulation.

Who is the study for?
This trial is for adults aged 22-70 with sleep issues, scoring >=8 on the ISI scale. Participants must be on a stable medication dose if they're taking psychiatric or sleep meds and use birth control if applicable. Excluded are those with TMS/MRI complications, certain mental health scores, hearing problems, implanted devices near the head, recent drug/device trials participation, metallic implants in the head, substance abuse issues, significant loss of consciousness history or diagnosed neurological diseases.
What is being tested?
The study is testing repetitive transcranial magnetic stimulation (rTMS) to see how it affects neurological symptoms. It's a forward-looking study where participants will undergo rTMS sessions and have their symptoms evaluated afterward to assess effectiveness and safety.
What are the potential side effects?
While not explicitly listed here, common side effects of rTMS can include headaches or discomfort at the stimulation site. Some individuals might experience lightheadedness or tingling sensations during treatment. Severe side effects like seizures are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a head injury that caused me to lose consciousness or was diagnosed as a concussion.
Select...
I have a history of neurological diseases like epilepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in multiple symptoms after rTMS treatment.
Secondary study objectives
Durability of changes in symptoms
Other study objectives
Safety Outcome

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Single Group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2016
Completed Phase 3
~840

Find a Location

Who is running the clinical trial?

NeuroneticsLead Sponsor
23 Previous Clinical Trials
7,552 Total Patients Enrolled
Steve EricksonStudy DirectorNeuronetics
~10 spots leftby Mar 2025
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