Anxiety StateNCT03623815
A Functional Magnetic Resonance Imaging Investigation of Transcranial Direct Current Stimulation
A study testing transcranial direct current stimulation in people with Anxiety State, run by University of Oxford.
Trial summary
This study evaluates the effect of frontal cortex transcranial direct current stimulation (tDCS) on the neural correlates of threat processing in healthy volunteers with a high level of trait anxiety. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety State
- What is being tested?
- transcranial direct current stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2015to 6 Oct 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Healthy female adults, right handed, aged 18-45 years.
- Participants will be asked to fill in a pre-screening online anxiety questionnaire (STAI-T) and will be invited to participate in the study if they score high within the normal range on trait anxiety.
Who cannot join
- Any current significant medical condition.
- Any current or past psychological disorder (for example depression or anorexia).
- Any family history of extreme mood fluctuations (such as elated mood states)
- Any current medications (except for contraceptive treatment) or herbal remedies such as St John's wort.
- Any current pregnancy or likelihood of becoming pregnant during the study.
- Any participation in any other psychological or medical experiment involving taking any kind of drugs, within the last 3 months.
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- Previous participation in a brain stimulation study will be taken into account and advice will be sought from the secondary supervisor on whether they should be included, based on the type of stimulation received, the location of the stimulation and the number of sessions. If the secondary supervisor advises that the nature of the stimulation previously received could affect the results of this study, the participant will not be included.
- Participants should not be claustrophobic, have a heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
- Any other contraindication to magnetic resonance imaging or transcranial current stimulation.
About this study
Official title: A Functional Magnetic Resonance Imaging Investigation Into the Effects of Transcranial Direct Current Stimulation on Information Processing in Healthy Volunteers
This study evaluates the effect of frontal cortex transcranial direct current stimulation (tDCS) on the neural correlates of threat processing in healthy volunteers with a high level of trait anxiety. All participants received both active and sham tDCS and underwent a functional imaging scan whilst carrying out an attentional control task with fearful distractors.
Read the detailed description
There is a growing body of evidence suggesting that repeated administration of prefrontal transcranial direct current stimulation (tDCS) is a potential effective treatment for depression through restoring a left/right imbalance in frontal brain activity (Boggio et al., 2008; Loo et al., 2012) and improving top down control of anxiety responses.
An initial exploratory study was carried out in 2012 (Ironside et al 2015) to examine the effects of tDCS on emotional processing in healthy volunteers using a range of tasks and questionnaires. Using a dot probe task, which measures attention to happy or fearful faces, it was found that tDCS has the potential ability to reverse an attentional bias to fearful faces seen in the placebo group. This indicates that anxiety responses may be modified using tDCS and therefore this follow on study seeks to further explore the role of tDCS in trait anxiety and investigate the neural correlates of this with fMRI.
The present study uses behavioural and neuroimaging results to examine how tDCS affects emotional processing relevant to trait anxiety. A within-subjects design increases the power of the study, given limited resources to carry out extensive neuroimaging. Our working hypothesis is that tDCS may alter activity in cortical regions relevant to attentional control and anxiety.
The findings of this study will be used to determine parameters for future patient studies, involving participants with generalized anxiety disorder or major depression. The ultimate aim, explored through further studies, is to understand and improve how tDCS might be used in the treatment of these disorders.
- Conditions
- Anxiety State
- Being tested
- transcranial direct current stimulation
- 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 direct current stimulationOther
Also called tDCS
Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulatory technique that uses weak electrical current to increase (with anodal) or decrease (with cathodal) the probability of brain activity in the stimulated region. This typically has acute effects relating to cortical activity levels which last up to one hour.
This intervention delivers 20 minutes of 2mA bipolar balanced tDCS, with anodal tDCS delivered to the left dorsolateral prefrontal cortex (DLPFC) and simultaneously cathodal tDCS delivered to the right DLPFC. In the sham condition 40 seconds of stimulation is delivered.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS followed by active tDCS | Other | Within subjects design. This group received sham (placebo) transcranial direct current stimulation (tDCS) for 20 minutes in session one. At least one month later this group received 2mA of active tDCS for 20 minutes in session two. Receives: Other: transcranial direct current stimulation |
| Active tDCS followed by sham tDCS | Other | Within subjects design. This group received 2mA of active transcranial direct current stimulation (tDCS) for 20 minutes in session one. At least one month later this group received sham (placebo) tDCS for 20 minutes in session two. Receives: Other: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in neural activity during an attentional control task after sham versus real tDCS
A comparison of neural activity (blood oxygenation level dependent response) during an attentional control task after real versus sham tDCS.
Measured: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
Secondary outcomes (6)
The change in accuracy in an attentional control task after sham versus real tDCS
A comparison of behavioural test results (accuracy in attentional control task) after real versus sham tDCS.
Measured: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in reaction time in an attentional control task after sham versus real tDCS
A comparison of behavioural test results (mean reaction time in milliseconds in attentional control task) after real versus sham tDCS.
Measured: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in self report anxiety after sham versus real tDCS
Differences in anxiety symptoms after sham versus real tDCS will be quantified by the change in self report anxiety scores (State-Trait Anxiety Inventory (STAI)) after sham tDCS and real tDCS.
Measured: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in sadness/happiness after sham versus real tDCS
Differences in sadness/happiness after sham versus real tDCS will be quantified by the change in self report visual analogue scale with sad at 0 and happy at 100 after sham tDCS and real tDCS.
Measured: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in hostility/friendliness after sham versus real tDCS
Differences in hostility/friendliness after sham versus real tDCS will be quantified by the change in self report visual analogue scale with hostile at 0 and friendly at 100 after sham tDCS and real tDCS.
Measured: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in calmness/tenseness after sham versus real tDCS
Differences in calmness/tenseness after sham versus real tDCS will be quantified by the change in self report visual analogue scale with calm at 0 and tense at 100 after sham tDCS and real tDCS.
Measured: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start5 Feb 2015
- Primary completion8 Sep 2015
- Study completion6 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo controlled crossover design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Catherine J Harmer, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623815
- Sponsor's protocol ID
- MS-IDREC-C2-2015-003
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loo CK, Alonzo A, Martin D, Mitchell PB, Galvez V, Sachdev P. Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial. Br J Psychiatry. 2012 Jan;200(1):52-9. doi: 10.1192/bjp.bp.111.097634.
PubMed 22215866Boggio PS, Zaghi S, Fregni F. Modulation of emotions associated with images of human pain using anodal transcranial direct current stimulation (tDCS). Neuropsychologia. 2009 Jan;47(1):212-7. doi: 10.1016/j.neuropsychologia.2008.07.022. Epub 2008 Aug 3.
PubMed 18725237Ironside M, O'Shea J, Cowen PJ, Harmer CJ. Frontal Cortex Stimulation Reduces Vigilance to Threat: Implications for the Treatment of Depression and Anxiety. Biol Psychiatry. 2016 May 15;79(10):823-830. doi: 10.1016/j.biopsych.2015.06.012. Epub 2015 Jun 17.
PubMed 26210058
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Functional Magnetic Resonance Imaging Investigation Into the Effects of Transcranial Direct Current Stimulation on Information Processing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03623815
- Acronym / sponsor ID
- MS-IDREC-C2-2015-003
- Conditions
- Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 8 Sep 2015 (actual)
- Study completion
- 6 Oct 2015 (actual)
- First posted
- 9 Aug 2018 (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.
This study evaluates the effect of frontal cortex transcranial direct current stimulation (tDCS) on the neural correlates of threat processing in healthy volunteers with a high level of trait anxiety. All participants received both active and sham tDCS and underwent a functional imaging scan whilst carrying out an attentional control task with fearful distractors.
Detailed description
There is a growing body of evidence suggesting that repeated administration of prefrontal transcranial direct current stimulation (tDCS) is a potential effective treatment for depression through restoring a left/right imbalance in frontal brain activity (Boggio et al., 2008; Loo et al., 2012) and improving top down control of anxiety responses.
An initial exploratory study was carried out in 2012 (Ironside et al 2015) to examine the effects of tDCS on emotional processing in healthy volunteers using a range of tasks and questionnaires. Using a dot probe task, which measures attention to happy or fearful faces, it was found that tDCS has the potential ability to reverse an attentional bias to fearful faces seen in the placebo group. This indicates that anxiety responses may be modified using tDCS and therefore this follow on study seeks to further explore the role of tDCS in trait anxiety and investigate the neural correlates of this with fMRI.
The present study uses behavioural and neuroimaging results to examine how tDCS affects emotional processing relevant to trait anxiety. A within-subjects design increases the power of the study, given limited resources to carry out extensive neuroimaging. Our working hypothesis is that tDCS may alter activity in cortical regions relevant to attentional control and anxiety.
The findings of this study will be used to determine parameters for future patient studies, involving participants with generalized anxiety disorder or major depression. The ultimate aim, explored through further studies, is to understand and improve how tDCS might be used in the treatment of these disorders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled crossover design
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS followed by active tDCS | Other | Other: transcranial direct current stimulationWithin subjects design. This group received sham (placebo) transcranial direct current stimulation (tDCS) for 20 minutes in session one. At least one month later this group received 2mA of active tDCS for 20 minutes in session two. |
| Active tDCS followed by sham tDCS | Other | Other: transcranial direct current stimulationWithin subjects design. This group received 2mA of active transcranial direct current stimulation (tDCS) for 20 minutes in session one. At least one month later this group received sham (placebo) tDCS for 20 minutes in session two. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Healthy female adults, right handed, aged 18-45 years.
- Participants will be asked to fill in a pre-screening online anxiety questionnaire (STAI-T) and will be invited to participate in the study if they score high within the normal range on trait anxiety.
Key exclusion criteria (9 listed)
- Any current significant medical condition.
- Any current or past psychological disorder (for example depression or anorexia).
- Any family history of extreme mood fluctuations (such as elated mood states)
- Any current medications (except for contraceptive treatment) or herbal remedies such as St John's wort.
- Any current pregnancy or likelihood of becoming pregnant during the study.
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 direct current stimulationAlso: tDCSTranscranial direct current stimulation (tDCS) is a non-invasive neuromodulatory technique that uses weak electrical current to increase (with anodal) or decrease (with cathodal) the probability of brain activity in the stimulated region. This typically has acute effects relating to cortical activity levels which last up to one hour. This intervention delivers 20 minutes of 2mA bipolar balanced tDCS, with anodal tDCS delivered to the left dorsolateral prefrontal cortex (DLPFC) and simultaneously cathodal tDCS delivered to the right DLPFC. In the sham condition 40 seconds of stimulation is delivered. | Other | Active tDCS followed by sham tDCS, Sham tDCS followed by active tDCS |
Primary outcome
The change in neural activity during an attentional control task after sham versus real tDCS
Time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
A comparison of neural activity (blood oxygenation level dependent response) during an attentional control task after real versus sham tDCS.
6 secondary outcomes
The change in accuracy in an attentional control task after sham versus real tDCS
Time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in reaction time in an attentional control task after sham versus real tDCS
Time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in self report anxiety after sham versus real tDCS
Time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in sadness/happiness after sham versus real tDCS
Time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in hostility/friendliness after sham versus real tDCS
Time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
The change in calmness/tenseness after sham versus real tDCS
Time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.
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 9 Aug 2018.
- Background: PubMed 22215866Loo CK, Alonzo A, Martin D, Mitchell PB, Galvez V, Sachdev P. Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial. Br J Psychiatry. 2012 Jan;200(1):52-9. doi: 10.1192/bjp.bp.111.097634.
- Background: PubMed 18725237Boggio PS, Zaghi S, Fregni F. Modulation of emotions associated with images of human pain using anodal transcranial direct current stimulation (tDCS). Neuropsychologia. 2009 Jan;47(1):212-7. doi: 10.1016/j.neuropsychologia.2008.07.022. Epub 2008 Aug 3.
- Background: PubMed 26210058Ironside M, O'Shea J, Cowen PJ, Harmer CJ. Frontal Cortex Stimulation Reduces Vigilance to Threat: Implications for the Treatment of Depression and Anxiety. Biol Psychiatry. 2016 May 15;79(10):823-830. doi: 10.1016/j.biopsych.2015.06.012. Epub 2015 Jun 17.
- 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.
Catherine J Harmer, PhD principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Anxiety State, run by University of Oxford.
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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The change in neural activity during an attentional control task after sham versus real tDCS (time frame: Outcome measure quantifies the change between measurement taken after real tDCS versus sham tDCS (order counterbalanced). The time period from the first measurement to the second and final measurement is no less than 30 days and no more than 60 days.). 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 NCT03623815, which also lists 3 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 9 Aug 2018.