A Functional Magnetic Resonance Imaging Investigation of Transcranial Direct Current Stimulation

NCT03623815 | Completed

• 1 other identifier: MS-IDREC-C2-2015-003
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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. All participants received both active and sham tDCS and underwent a functional imaging scan whilst carrying out an attentional control task with fearful distractors.

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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.

Study Arms (2)

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.

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.

Other: transcranial direct current stimulation

Interventions

transcranial direct current stimulation OTHER

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.

Also known as: tDCS

Active tDCS followed by sham tDCS; Sham tDCS followed by active tDCS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Oxford: lead
• Medical Research Council: collaborator

Related Publications (3)

• 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.

  PMID: 22215866 BACKGROUND

• Boggio 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.

  PMID: 18725237 BACKGROUND

• Ironside 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.

  PMID: 26210058 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Catherine J Harmer, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double blinding was carried out using a blinding code randomly assigned to each participant by a separate party. This code was entered into the transcranial direct current stimulation device by the investigator to deliver the stimulation. The investigator was not unblinded until initial analysis was complete.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo controlled crossover design

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 9, 2018
• Study Start: February 5, 2015
• Primary Completion: September 8, 2015
• Study Completion: October 6, 2015
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share