Healthy SubjectsTMSINS02NCT02919423
TMS Modulation of Insula-related Brain Networks.02
A study testing transcranial magnetic stimulation in people with Healthy Subjects, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 25 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- generally healthy
- between the ages of 18-55
- right-handed
Who cannot join
- significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)
- current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
- meet DSM-5 criteria for current substance use disorder other than nicotine
- use of psychoactive medications that would result in a positive urine drug screen
- Current use of medications known to lower the seizure threshold
- positive breath alcohol concentration
Show all 9Show fewer
- presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)
- among women, a positive urine pregnancy test
- vision that cannot be corrected to 20/40
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.
- Conditions
- Healthy Subjects
- Being tested
- transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 10 Hz TMS | Active comparator | active TMS will be administered Receives: Device: transcranial magnetic stimulation |
| 1 Hz TMS | Active comparator | active TMS will be administered Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging
Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.
Measured: baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy SubjectsStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merideth Addicott, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919423
- Sponsor's protocol ID
- Pro00077293
- Acronym
- TMSINS02
- Status last verified
- Jan 2019
- First submitted
- 28 Sep 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS Modulation of Insula-related Brain Networks.02
- ClinicalTrials.gov ID
- NCT02919423
- Acronym / sponsor ID
- TMSINS02 / Pro00077293
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 15 Feb 2019
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 the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 Hz TMS | Active comparator | Device: transcranial magnetic stimulationactive TMS will be administered |
| 1 Hz TMS | Active comparator | Device: transcranial magnetic stimulationactive TMS will be administered |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- generally healthy
- between the ages of 18-55
- right-handed
Key exclusion criteria (9 listed)
- significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)
- current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)
- meet DSM-5 criteria for current substance use disorder other than nicotine
- use of psychoactive medications that would result in a positive urine drug screen
- Current use of medications known to lower the seizure threshold
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 |
|---|---|---|
| transcranial magnetic stimulation | Device | 1 Hz TMS, 10 Hz TMS |
Primary outcome
Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging
Time frame: baseline and 1 week
Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Merideth Addicott, PhD 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 transcranial magnetic stimulation in people with Healthy Subjects, 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 9 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: finished, as of the sponsor's last update on 15 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging (time frame: baseline and 1 week). 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 15 Feb 2019.