Human Brain ActivityNCT03259568
Effects of rTMS on Human Brain Activity Measured With fMRI
A study testing Repetitive TMS in people with Human Brain Activity, run by Duke University at 1 site in United States.
Trial summary
This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Brain Activity
- What is being tested?
- Repetitive TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 20 Aug 2019
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-30.
- 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) of 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); [TMS Adult Safety Screening (TASS) form].
- 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 22Show 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.
- Mini Mental Status Exam (MMSE) score of <24.
- 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).
- Blindness.
- Inability to read or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Leveraging our expertise in application of TMS methodology during concurrent single neuron recording techniques in non-human primates and imaging and scalp potential techniques in humans, the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.
- Conditions
- Human Brain Activity
- Being tested
- Repetitive TMS
- Keywords
- TMS, BOLD activity, Network activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive TMSDevice
1-10 Hertz rTMS will be administered
| Study group | Role | What they receive |
|---|---|---|
| Dose-response TMS - Intensity = 20%RMT | Experimental | Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal. Receives: Device: Repetitive TMS |
| Dose-response TMS - Intensity = 40%RMT | Experimental | Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal. Receives: Device: Repetitive TMS |
| Dose-response TMS - Intensity = 80%RMT | Experimental | Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal. Receives: Device: Repetitive TMS |
| Dose-response TMS - Intensity = 120%RMT | Experimental | Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal. Receives: Device: Repetitive TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motion Perception Accuracy
Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)
Measured: during each TMS session, up to 3 hours
Reaction Time
Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)
Measured: during each TMS session, up to 3 hours
Activation of Cortical Networks During a Visual Motion Task.
Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal
Measured: during each TMS session, up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start12 Jan 2018
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Why it stopped: Slow enrollment due to Covid-19.
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 Human Brain ActivityStudies 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- The study is a within-subjects design focused on estimating the fMRI BOLD response to different levels of TMS intensity. The conditions in the study ("arms") are repeated within each participant (20%, 40%, 80%, or 120% of an individual's titrated resting motor threshold).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259568
- Sponsor's protocol ID
- Pro00082433
- Status last verified
- Mar 2023
- First submitted
- 15 Aug 2017
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Mar 2023. 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
- NCT03259568
- Acronym / sponsor ID
- Pro00082433
- Conditions
- Human Brain Activity
- Keywords
- TMS, BOLD activity, Network activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment due to Covid-19.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Leveraging our expertise in application of TMS methodology during concurrent single neuron recording techniques in non-human primates and imaging and scalp potential techniques in humans, the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The study is a within-subjects design focused on estimating the fMRI BOLD response to different levels of TMS intensity. The conditions in the study ("arms") are repeated within each participant (20%, 40%, 80%, or 120% of an individual's titrated resting motor threshold).
| Arm | Type | Receives |
|---|---|---|
| Dose-response TMS - Intensity = 20%RMT | Experimental | Device: Repetitive TMSFour levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
| Dose-response TMS - Intensity = 40%RMT | Experimental | Device: Repetitive TMSFour levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
| Dose-response TMS - Intensity = 80%RMT | Experimental | Device: Repetitive TMSFour levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
| Dose-response TMS - Intensity = 120%RMT | Experimental | Device: Repetitive TMSFour levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI. Outcome measures include accuracy, RT, and BOLD signal. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-30.
- Use of effective method of birth control for women of childbearing capacity.
- Willing to provide informed consent.
Key exclusion criteria (22 listed)
- Current or recent (within the past 6 months) of 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); [TMS Adult Safety Screening (TASS) form].
- 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 |
|---|---|---|
| Repetitive TMS1-10 Hertz rTMS will be administered | Device | Dose-response TMS - Intensity = 120%RMT, Dose-response TMS - Intensity = 20%RMT, Dose-response TMS - Intensity = 40%RMT, Dose-response TMS - Intensity = 80%RMT |
Primary outcome
Motion Perception Accuracy
Time frame: during each TMS session, up to 3 hours
Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)
Reaction Time
Time frame: during each TMS session, up to 3 hours
Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)
Activation of Cortical Networks During a Visual Motion Task.
Time frame: during each TMS session, up to 3 hours
Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive TMS in people with Human Brain Activity, 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 22 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: stopped early, as of the sponsor's last update on 29 Mar 2023. 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 29 Mar 2023). 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?
Motion Perception Accuracy (time frame: during each TMS session, up to 3 hours). 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 29 Mar 2023.