Healthy VolunteersNCT03027414
Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
A study testing Transcranial Magnetic Stimulation in people with Healthy Volunteers, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Researchers want to better understand brain processes related to fear and anxiety. They want to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can reduce anxiety. Objective: To see how TMS affects fear and anxiety through memory and attention tasks. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2017to 29 Jun 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-50
- Subjects able to give their consent
- Right handed
Who cannot join
- Non-English speaking individual
- Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- Current or past Axis I psychiatric disorder(s) as identified with the Structured Clinical Interview for DSM-IV, non-patient edition (SCID-np)
- Active or history of active suicidal ideation.
- Evidence of a first-degree relative with history of psychosis or bipolar disorder; specifically, participant will know diagnosis or treatment in order to confirm presence of disorder.
- Alcohol/drug problems in the past year or lifetime alcohol or drug dependence according to the Structured Clinical Interview for DSM-IV.
Show all 21Show fewer
- Current use of medications that act on histamine (i.e. diphenhydramine), dopamine (methylphenidate), norepinephrine (buproprion), serotonin (sertraline), or acetylcholine (amitryptiline) receptors. Subjects will be excluded on this basis if they either 1) take these medications on a chronic basis, or 2) if they have taken the drug within 5 half-lives of the drug metabolism, determined by the medical professional at the time of screening.
- History of seizure (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.
- 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 (table below).
- Pregnancy, or positive pregnancy test.
- Neurological syndrome of the arm (e.g., carpal tunnel syndrome, cubital tunnel syndrome, etc.)
- Positive urine toxicology screen during the screening visit.
- IQ <80
- Employee or staff of NIMH or are an immediate family member of a NIMH employee, staff, or NIMH contractors.
- Allergy to lidocaine or topical anesthetics (participants in sub-study 3 only).
- Any medical condition that increases risk for fMRI or TMS:
- Any metal in their body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may small metal fragments in the eye.
- Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
- Patients who have difficulty lying flat on their back for up to 60 min in the scanner
- History of hearing loss
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
Background:
Researchers want to better understand brain processes related to fear and anxiety. They want to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can reduce anxiety.
Read more
Objective:
To see how TMS affects fear and anxiety through memory and attention tasks.
Eligibility:
Healthy people ages 18-50 who are right-handed
Design:
Participants will be screened through another protocol.
Participants in the pilot study will have 1 visit. This includes:
Urine tests
Questionnaires about mood and thinking
Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will be shocked to find out what level of shock is uncomfortable but tolerable. They will hear loud, sudden noises through headphones.
TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they might receive fake TMS. This feels the same as real TMS. They will perform simple tasks. Participants in the main study will have 2 visits within 2 weeks.
The first visit includes:
Urine tests
Questionnaires about mood and thinking
MRI: Participants lie on a table that slides into a scanner. They will be in the scanner about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.
The second visit includes:
Shock and startle workup
TMS
Read the detailed description
Objective: To determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects. Toward this aim we will test the effect of transcranial magnetic stimulation (TMS) on two outcome measures: 1) Fear and anxiety during the threat of predictable and unpredictable shock (NPU threat test; Substudies 1 and 3), and 2) Working memory (WM) related anxiety downregulation while performing the Sternberg WM task under threat of shock (Substudy 2).
Study population: The study population will consist of up to 184 healthy volunteers between the ages of 18-50.
Design: This study will consists of two (sub-studies 1 and 2) or three (sub-study 3) outpatient visits (1 MRI, 1 or 2 TMS visits [2 for sub-study 3]). In this protocol we will explore the effect of TMS in three sub-studies in the TMS study visit. The sub-studies will contain either the NPU or the Sternberg task during the TMS visits. The first visit (MRI) will consist of the same procedures for all sub-studies. Each subject will be assigned to only one of the sub-studies.
Sternberg Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the Sternberg WM task. Subjects will have to maintain a series of letters in WM for a brief interval during blocks of safety and threat of shock.
NPU Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the NPU threat test. Subjects will be exposed to blocks in which they are either 1) safe from shock (neutral), 2) at risk of shock delivered only during a cue (predictable), or 3) at risk of shock presented randomly (unpredictable).
Outcome measures: In both studies the primary outcome measure will be anxiety-potentiated startle (APS), which is the increase in startle magnitude during periods of threat compared to periods of safety. We expect active, but not sham TMS to increase activity in the dlPFC, and therefore reduce APS in both studies
- Conditions
- Healthy Volunteers
- Being tested
- Transcranial Magnetic Stimulation Sham, Transcranial Magnetic Stimulation
- Keywords
- Anxiety, Startle, Dorsolateral Prefrontal Cortex, Transcranial Magnetic Stimulation (TMS), Working Memory
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation ShamDrug
TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.
Transcranial Magnetic StimulationDevice
TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1 Active and Sham | Experimental | HVs that receive TMS over the right dlPFC Receives: Drug: Transcranial Magnetic Stimulation Sham; Device: Transcranial Magnetic Stimulation |
| Substudy 2 Active and Sham | Experimental | HVs that receive TMS over the right dlFPC Receives: Drug: Transcranial Magnetic Stimulation Sham; Device: Transcranial Magnetic Stimulation |
| Substudy 3 Active and Sham | Experimental | HVs will receive offline TMS to the lest IPS (FPN) Receives: Drug: Transcranial Magnetic Stimulation Sham; Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety-potentiated Startle
Electromyography Facial electromyography (EMG) startle responses were recorded from the left orbicularis oculi muscle at 2000 Hz using a Biopac MP160 unit (Biopac; Goleta, CA) via 15 × 20 mm hydrogel coated vinyl electrodes (Rhythmlink #DECUS10026; Columbia, SC).
Startle EMG was bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses were scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores with a mean of 50 and a standard deviation of 10 (tx = [Zx × 10] + 50). Greater t-scores mean larger blinks, which could be associated with greater anxiety, however there is no clinically relevent threshold. Noisy trials (baseline SD > 2x run SD) were excluded, and "no blink" (peak < baseline range) trials were coded as 0. To calculate APS, we subtracted the response during the neutral ITI from the response during the unpredictable ITI.
Measured: Pre and post stimulation
Working Memory (WM) Related Anxiety Downregulation While Performing the Sternberg WM Task Under Threat of Shock.
Sternberg Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the Sternberg WM task. Subjects will have to maintain a series of letters in WM for a brief interval during blocks of safety and threat of shock.
Electromyography Facial electromyography (EMG) startle responses are recorded from the left orbicularis oculi muscle at 2000 Hz.
Startle EMG is bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses are scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores (tx = [Zx × 10] + 50). Noisy trials (baseline SD > 2x run SD) are excluded, and "no blink" (peak < baseline range) trials are coded as 0. These t scores are then averaged across trials within each condition, and threat-safe contrasts are calculated independently for each level of load (low vs. high) and timing (maintenance vs. ITI).
Measured: Pre and post stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start23 Jan 2017
- Primary completion19 Jul 2019
- Study completion29 Jun 2020
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christian Grillon, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027414
- Sponsor's protocol ID
- 170042
- Other IDs
- 17-M-0042
- Status last verified
- Jun 2020
- First submitted
- 18 Jan 2017
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Balderston NL, Quispe-Escudero D, Hale E, Davis A, O'Connell K, Ernst M, Grillon C. Working memory maintenance is sufficient to reduce state anxiety. Psychophysiology. 2016 Nov;53(11):1660-1668. doi: 10.1111/psyp.12726. Epub 2016 Jul 19.
PubMed 27434207Schmitz A, Grillon C. Assessing fear and anxiety in humans using the threat of predictable and unpredictable aversive events (the NPU-threat test). Nat Protoc. 2012 Feb 23;7(3):527-32. doi: 10.1038/nprot.2012.001.
PubMed 22362158Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we expand the toolbox of psychiatric treatment methods to include Repetitive Transcranial Magnetic Stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. J Clin Psychiatry. 2010 Jul;71(7):873-84. doi: 10.4088/JCP.08m04872gre. Epub 2010 Mar 9.
PubMed 20361902Balderston NL, Roberts C, Beydler EM, Deng ZD, Radman T, Luber B, Lisanby SH, Ernst M, Grillon C. A generalized workflow for conducting electric field-optimized, fMRI-guided, transcranial magnetic stimulation. Nat Protoc. 2020 Nov;15(11):3595-3614. doi: 10.1038/s41596-020-0387-4. Epub 2020 Sep 30.
PubMed 33005039
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Magnetic Stimulation to the Frontoparietal Attention Network on Anxiety Potentiated Startle
- ClinicalTrials.gov ID
- NCT03027414
- Acronym / sponsor ID
- 170042
- Conditions
- Healthy Volunteers
- Keywords
- Anxiety, Startle, Dorsolateral Prefrontal Cortex, Transcranial Magnetic Stimulation (TMS), Working Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Researchers want to better understand brain processes related to fear and anxiety. They want to find out if transcranial magnetic stimulation (TMS), a type of brain stimulation, can reduce anxiety.
Objective:
To see how TMS affects fear and anxiety through memory and attention tasks.
Eligibility:
Healthy people ages 18-50 who are right-handed
Design:
Participants will be screened through another protocol.
Participants in the pilot study will have 1 visit. This includes:
Urine tests
Questionnaires about mood and thinking
Shock and startle workup: Electrodes are taped to the wrists or fingers. Participants will be shocked to find out what level of shock is uncomfortable but tolerable. They will hear loud, sudden noises through headphones.
TMS: A coil is held on the scalp. A magnetic field stimulates the brain. Sometimes they might receive fake TMS. This feels the same as real TMS. They will perform simple tasks. Participants in the main study will have 2 visits within 2 weeks.
The first visit includes:
Urine tests
Questionnaires about mood and thinking
MRI: Participants lie on a table that slides into a scanner. They will be in the scanner about 1 hour. A computer screen in the scanner will tell them to perform simple tasks.
The second visit includes:
Shock and startle workup
TMS
Detailed description
Objective: To determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects. Toward this aim we will test the effect of transcranial magnetic stimulation (TMS) on two outcome measures: 1) Fear and anxiety during the threat of predictable and unpredictable shock (NPU threat test; Substudies 1 and 3), and 2) Working memory (WM) related anxiety downregulation while performing the Sternberg WM task under threat of shock (Substudy 2).
Study population: The study population will consist of up to 184 healthy volunteers between the ages of 18-50.
Design: This study will consists of two (sub-studies 1 and 2) or three (sub-study 3) outpatient visits (1 MRI, 1 or 2 TMS visits [2 for sub-study 3]). In this protocol we will explore the effect of TMS in three sub-studies in the TMS study visit. The sub-studies will contain either the NPU or the Sternberg task during the TMS visits. The first visit (MRI) will consist of the same procedures for all sub-studies. Each subject will be assigned to only one of the sub-studies.
Sternberg Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the Sternberg WM task. Subjects will have to maintain a series of letters in WM for a brief interval during blocks of safety and threat of shock.
NPU Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the NPU threat test. Subjects will be exposed to blocks in which they are either 1) safe from shock (neutral), 2) at risk of shock delivered only during a cue (predictable), or 3) at risk of shock presented randomly (unpredictable).
Outcome measures: In both studies the primary outcome measure will be anxiety-potentiated startle (APS), which is the increase in startle magnitude during periods of threat compared to periods of safety. We expect active, but not sham TMS to increase activity in the dlPFC, and therefore reduce APS in both studies
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Substudy 1 Active and Sham | Experimental | Drug: Transcranial Magnetic Stimulation Sham, Device: Transcranial Magnetic StimulationHVs that receive TMS over the right dlPFC |
| Substudy 2 Active and Sham | Experimental | Drug: Transcranial Magnetic Stimulation Sham, Device: Transcranial Magnetic StimulationHVs that receive TMS over the right dlFPC |
| Substudy 3 Active and Sham | Experimental | Drug: Transcranial Magnetic Stimulation Sham, Device: Transcranial Magnetic StimulationHVs will receive offline TMS to the lest IPS (FPN) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-50
- Subjects able to give their consent
- Right handed
Key exclusion criteria (21 listed)
- Non-English speaking individual
- Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
- Current or past Axis I psychiatric disorder(s) as identified with the Structured Clinical Interview for DSM-IV, non-patient edition (SCID-np)
- Active or history of active suicidal ideation.
- Evidence of a first-degree relative with history of psychosis or bipolar disorder; specifically, participant will know diagnosis or treatment in order to confirm presence of disorder.
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 ShamTMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects. | Drug | Substudy 1 Active and Sham, Substudy 2 Active and Sham, Substudy 3 Active and Sham |
| Transcranial Magnetic StimulationTMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects. | Device | Substudy 1 Active and Sham, Substudy 2 Active and Sham, Substudy 3 Active and Sham |
Primary outcome
Anxiety-potentiated Startle
Time frame: Pre and post stimulation
Electromyography Facial electromyography (EMG) startle responses were recorded from the left orbicularis oculi muscle at 2000 Hz using a Biopac MP160 unit (Biopac; Goleta, CA) via 15 × 20 mm hydrogel coated vinyl electrodes (Rhythmlink #DECUS10026; Columbia, SC). Startle EMG was bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses were scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores with a mean of 50 and a standard deviation of 10 (tx = [Zx × 10] + 50). Greater t-scores mean larger blinks, which could be associated with greater anxiety, however there is no clinically relevent threshold. Noisy trials (baseline SD > 2x run SD) were excluded, and "no blink" (peak < baseline range) trials were coded as 0. To calculate APS, we subtracted the response during the neutral ITI from the response during the unpredictable ITI.
Working Memory (WM) Related Anxiety Downregulation While Performing the Sternberg WM Task Under Threat of Shock.
Time frame: Pre and post stimulation
Sternberg Task: Expose subjects to active or sham TMS to a region of the frontoparietal attention network during the Sternberg WM task. Subjects will have to maintain a series of letters in WM for a brief interval during blocks of safety and threat of shock. Electromyography Facial electromyography (EMG) startle responses are recorded from the left orbicularis oculi muscle at 2000 Hz. Startle EMG is bandpass filtered from 30 to 300 Hz, rectified, and smoothed using a 20-ms sliding window. Startle responses are scored as the peak (max during the 20 ms to 120 ms post-noise window) - the baseline (50 ms pre-noise window), and converted to t-scores (tx = [Zx × 10] + 50). Noisy trials (baseline SD > 2x run SD) are excluded, and "no blink" (peak < baseline range) trials are coded as 0. These t scores are then averaged across trials within each condition, and threat-safe contrasts are calculated independently for each level of load (low vs. high) and timing (maintenance vs. ITI).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27434207Balderston NL, Quispe-Escudero D, Hale E, Davis A, O'Connell K, Ernst M, Grillon C. Working memory maintenance is sufficient to reduce state anxiety. Psychophysiology. 2016 Nov;53(11):1660-1668. doi: 10.1111/psyp.12726. Epub 2016 Jul 19.
- Background: PubMed 22362158Schmitz A, Grillon C. Assessing fear and anxiety in humans using the threat of predictable and unpredictable aversive events (the NPU-threat test). Nat Protoc. 2012 Feb 23;7(3):527-32. doi: 10.1038/nprot.2012.001.
- Background: PubMed 20361902Slotema CW, Blom JD, Hoek HW, Sommer IE. Should we expand the toolbox of psychiatric treatment methods to include Repetitive Transcranial Magnetic Stimulation (rTMS)? A meta-analysis of the efficacy of rTMS in psychiatric disorders. J Clin Psychiatry. 2010 Jul;71(7):873-84. doi: 10.4088/JCP.08m04872gre. Epub 2010 Mar 9.
- Derived from this study: PubMed 33005039Balderston NL, Roberts C, Beydler EM, Deng ZD, Radman T, Luber B, Lisanby SH, Ernst M, Grillon C. A generalized workflow for conducting electric field-optimized, fMRI-guided, transcranial magnetic stimulation. Nat Protoc. 2020 Nov;15(11):3595-3614. doi: 10.1038/s41596-020-0387-4. Epub 2020 Sep 30.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Screening Protocol
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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.
Christian Grillon, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
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 Volunteers, run by National Institute of Mental Health (NIMH) 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 21 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 17 May 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. 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 17 May 2022). 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?
Anxiety-potentiated Startle (time frame: Pre and post stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027414, which also lists 4 linked publications.
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 17 May 2022.