Repetitive Transcranial Magnetic Stimulation (rTMS)NCT04242810
Effects of rTMS on Human Brain Activity
A study testing rTMS and MRI scan in people with Repetitive Transcranial Magnetic Stimulation (rTMS), run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks measured by functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- What is being tested?
- rTMS and MRI scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age restrictions: between 18-35 years old
- Use of effective method of birth control for women of childbearing capacity.
- Willing to provide informed consent.
Who cannot join
- Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (urine test)
- Current serious medical illness (self-report)
- History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Subjects are unable or unwilling to give informed consent
- Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
- Subjects with a clinically defined neurological disorder including, but not limited to:
Show all 19Show fewer
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion.
- History of stroke.
- Transient ischemic attack within two years.
- Cerebral aneurysm.
- Dementia.
- Parkinson's disease.
- Huntington's disease.
- Multiple sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold
- Subjects with cochlear implants
- Subjects not willing to tolerate the confinement associated with being in the MRI scanner
- Women who are pregnant or breast-feeding (urine test)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of rTMS on Human Brain Activity Measured With fMRI
The purpose of this study is to investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks measured by functional magnetic resonance imaging (fMRI).
Participants will undergo a screening that includes a psychiatric and medical history screening, TMS and MRI safety screening, and urine screening. If participants pass the screening procedure, they will be introduced to transcranial magnetic stimulation (TMS), magnetic resonance imaging (MRI), and a task that involves viewing words, sentences, or pictures. There will be up to seven visits and each visit will take less than 3 hours.
MRI can be dangerous for people that have medical devices, metal objects, or metal debris in their bodies. TMS procedures are associated with a very low risk of seizures, "muscle-tension" type headache, ear damage, numbness of the face, fainting, dizziness, memory impairment, trouble concentrating, and acute mood changes. This study will use only levels of TMS that are within safety guidelines. There is also a risk of potential loss of confidentiality.
- Being tested
- rTMS, Sham rTMS, MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
TMS will be applied over task-based target at an intensity up of 130% rMT. The optimal coil placement during stimulation will be guided using the BrainSight neuronavigation system.
Sham rTMSDevice
An electrical sham coil that produces the same auditory and somatosensory stimulations, without a significant magnetic field, will be used as an active control.
MRI scanProcedure or surgery
Participants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | rTMS applied over memory task-based brain target Receives: Device: rTMS; Procedure: MRI scan |
| Sham rTMS | Placebo comparator | Sham rTMS applied over memory task-based brain target Receives: Device: Sham rTMS; Procedure: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a rTMS session on the performance for a memory task, as measured by accuracy (in percentage of correct responses)
Measured: up to 1 month
An effect of a rTMS session on the performance for a memory task, as measured by reaction time (in ms)
Measured: Time frame: up to 1 month
An effect of a rTMS session on fMRI brain representation for a memory task, as measured by BOLD signal
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startDec 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Never started enrollment due to COVID-19 closures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Transcranial Magnetic Stimulation (rTMS)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Cabeza, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242810
- Sponsor's protocol ID
- Pro00102980
- Status last verified
- Dec 2021
- First submitted
- 23 Jan 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of rTMS on Human Brain Activity Measured With fMRI
- ClinicalTrials.gov ID
- NCT04242810
- Acronym / sponsor ID
- Pro00102980
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never started enrollment due to COVID-19 closures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Jan 2020 (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.
The purpose of this study is to investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks measured by functional magnetic resonance imaging (fMRI).
Participants will undergo a screening that includes a psychiatric and medical history screening, TMS and MRI safety screening, and urine screening. If participants pass the screening procedure, they will be introduced to transcranial magnetic stimulation (TMS), magnetic resonance imaging (MRI), and a task that involves viewing words, sentences, or pictures. There will be up to seven visits and each visit will take less than 3 hours.
MRI can be dangerous for people that have medical devices, metal objects, or metal debris in their bodies. TMS procedures are associated with a very low risk of seizures, "muscle-tension" type headache, ear damage, numbness of the face, fainting, dizziness, memory impairment, trouble concentrating, and acute mood changes. This study will use only levels of TMS that are within safety guidelines. There is also a risk of potential loss of confidentiality.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: rTMS, Procedure: MRI scanrTMS applied over memory task-based brain target |
| Sham rTMS | Placebo comparator | Device: Sham rTMS, Procedure: MRI scanSham rTMS applied over memory task-based brain target |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age restrictions: between 18-35 years old
- Use of effective method of birth control for women of childbearing capacity.
- Willing to provide informed consent.
Key exclusion criteria (19 listed)
- Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (urine test)
- Current serious medical illness (self-report)
- History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Subjects are unable or unwilling to give informed consent
- Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
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 |
|---|---|---|
| rTMSTMS will be applied over task-based target at an intensity up of 130% rMT. The optimal coil placement during stimulation will be guided using the BrainSight neuronavigation system. | Device | Active rTMS |
| Sham rTMSAn electrical sham coil that produces the same auditory and somatosensory stimulations, without a significant magnetic field, will be used as an active control. | Device | Sham rTMS |
| MRI scanParticipants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures. | Procedure or surgery | Active rTMS, Sham rTMS |
Primary outcome
Effect of a rTMS session on the performance for a memory task, as measured by accuracy (in percentage of correct responses)
Time frame: up to 1 month
An effect of a rTMS session on the performance for a memory task, as measured by reaction time (in ms)
Time frame: Time frame: up to 1 month
An effect of a rTMS session on fMRI brain representation for a memory task, as measured by BOLD signal
Time frame: up to 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Robert Cabeza principal investigator
Duke University
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 and MRI scan in people with Repetitive Transcranial Magnetic Stimulation (rTMS), run by Duke University 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 3 inclusion and 19 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: withdrawn, as of the sponsor's last update on 10 Jan 2022. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effect of a rTMS session on the performance for a memory task, as measured by accuracy (in percentage of correct responses) (time frame: up to 1 month). The study lists 3 primary outcomes in all. 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 10 Jan 2022.