Healthy VolunteersNCT02616835
Investigating the Physiology of Targeted Theta-burst Neuromodulation
A study testing theta-burst TMS in people with Healthy Volunteers, run by Institute of Mental Health Nottingham at 1 site in United Kingdom.
Trial summary
This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- theta-burst TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Jun 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No personal history of neurological or psychiatric disorders
Who cannot join
- Have had a brain injury or neurological disorder
- Have ever suffered an epileptic fit
- Have any non-removable metal implants
- Drink more than 20 units of alcohol per week on a regular basis
- Currently take any illicit drugs on regular basis
- Likely to be pregnant
- Ever suffered from a serious mental illness such as schizophrenia, severe depression or bipolar disorder
- Currently take any psychotropic medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sarina Iwabuchi
Nottingham, Nottinghamshire, NG7 2TU
About this study
This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.
- Conditions
- Healthy Volunteers
- Being tested
- theta-burst TMS, sham theta-burst TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theta-burst TMSDevice
This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.
sham theta-burst TMSDevice
This protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output)
| Study group | Role | What they receive |
|---|---|---|
| theta-burst TMS | Experimental | Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) Receives: Device: theta-burst TMS |
| sham theta-burst TMS | Sham comparator | Sham protocol for theta-burst transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) Receives: Device: sham theta-burst TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional connectivity following TMS administration using functional MRI
Changes in brain connectivity will be assessed by comparing functional MRI scans after theta-burst TMS and sham theta-burst TMS
Measured: One hour
Secondary outcomes (1)
Changes in brain metabolites following TMS administration using MR spectroscopy
Using MRI scans, changes in metabolites in the brain will be assessed following theta-burst TMS and sham TMS
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarina Iwabuchi, Institute of Mental Health Nottingham
- Investigators
- Sarina Iwabuchi, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616835
- Sponsor's protocol ID
- L14082014 SoM PAPsych
- Status last verified
- Nov 2015
- First submitted
- 24 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Physiology of Targeted Theta-burst Neuromodulation
- ClinicalTrials.gov ID
- NCT02616835
- Acronym / sponsor ID
- L14082014 SoM PAPsych
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Institute of Mental Health NottinghamUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Nov 2015 (estimated)
- 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.
This research seeks to study the physiological effects of theta-burst transcranial magnetic stimulation (TMS) in the brains of healthy controls using functional MRI and spectroscopy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| theta-burst TMS | Experimental | Device: theta-burst TMSTheta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) |
| sham theta-burst TMS | Sham comparator | Device: sham theta-burst TMSSham protocol for theta-burst transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No personal history of neurological or psychiatric disorders
Key exclusion criteria (8 listed)
- Have had a brain injury or neurological disorder
- Have ever suffered an epileptic fit
- Have any non-removable metal implants
- Drink more than 20 units of alcohol per week on a regular basis
- Currently take any illicit drugs on regular basis
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 |
|---|---|---|
| theta-burst TMSThis protocol involves short periods of pulse delivery in combination with long periods of silent intervals. | Device | theta-burst TMS |
| sham theta-burst TMSThis protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output) | Device | sham theta-burst TMS |
Primary outcome
Changes in functional connectivity following TMS administration using functional MRI
Time frame: One hour
Changes in brain connectivity will be assessed by comparing functional MRI scans after theta-burst TMS and sham theta-burst TMS
1 secondary outcome
Changes in brain metabolites following TMS administration using MR spectroscopy
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Sarina Iwabuchi, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing theta-burst TMS in people with Healthy Volunteers, run by Institute of Mental Health Nottingham at 1 site in United Kingdom.
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 1 inclusion and 8 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 30 Nov 2015. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 functional connectivity following TMS administration using functional MRI (time frame: One hour). 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 30 Nov 2015.