Neurologic SymptomsSETNCT06429748
Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation
A study testing rTMS in people with Neurologic Symptoms, run by Neuronetics at 1 site in United States.
Trial summary
A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Neurologic Symptoms
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 22 to 70 years of age
- Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
- Score > or = 8 on ISI scale
- If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
- If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
- Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.
Who cannot join
- Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
- History of head trauma associated with loss of consciousness or diagnosed as concussion.
- History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
- Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
- Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
- Has medication infusion device.
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- Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
- PHQ-9 total score > or = 10 or QIDS total score > or = 11.
- Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
- Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
- Other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like Obstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by DSM-V-TR.
- Has a clinically significant abnormality on the screening examination.
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charlotte Skin and Laser
Charlotte, North Carolina, 28207
About this study
Official title: A Prospective Study to Evaluate Symptoms Following Repetitive Transcranial Magnetic Stimulation (rTMS)
A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.
Read the detailed description
Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.
- Conditions
- Neurologic Symptoms
- Being tested
- rTMS
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
repetitive Transcranial Magnetic Stimultion
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Single Group Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in multiple symptoms after rTMS treatment.
Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to end of acute.
Measured: 4 weeks
Secondary outcomes (1)
Durability of changes in symptoms
Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to final follow-up visit.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start15 May 2024
- Primary completion29 Apr 2025
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuronetics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Erickson, Study director, Neuronetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429748
- Sponsor's protocol ID
- 44-50019-000
- Acronym
- SET
- Status last verified
- Jun 2026
- First submitted
- 21 May 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate Symptoms Following Repetitive Transcranial Magnetic Stimulation (rTMS)
- ClinicalTrials.gov ID
- NCT06429748
- Acronym / sponsor ID
- SET / 44-50019-000
- Conditions
- Neurologic Symptoms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NeuroneticsUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.
Detailed description
Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Device: rTMSSingle Group |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults, 22 to 70 years of age
- Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
- Score > or = 8 on ISI scale
- If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
- If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
Key exclusion criteria (13 listed)
- Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
- History of head trauma associated with loss of consciousness or diagnosed as concussion.
- History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
- Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
- Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSrepetitive Transcranial Magnetic Stimultion | Device | Open Label |
Primary outcome
Changes in multiple symptoms after rTMS treatment.
Time frame: 4 weeks
Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to end of acute.
1 secondary outcome
Durability of changes in symptoms
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Erickson study director
Neuronetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Neurologic Symptoms, run by Neuronetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in multiple symptoms after rTMS treatment. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.