14 Participants Needed

Brain Stimulation for Suicide Risk

(ENACTS Trial)

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Overseen ByCasey S Gilmore, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests a short-term treatment using a gentle brain treatment and exercises to help Veterans improve decision-making and reduce suicidal thoughts and behaviors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for reducing suicide risk?

Research suggests that transcranial direct current stimulation (tDCS) may help with depression, which is often linked to suicide risk. Some studies show tDCS can improve mood and cognitive function in people with depression, potentially reducing factors that contribute to suicidal thoughts.12345

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no reports of serious adverse effects in over 33,200 sessions and 1,000 subjects, including vulnerable populations. Common mild side effects include itching, tingling, and headaches, but these are not significantly different from those experienced with placebo treatments.678910

How is the treatment Active Transcranial Direct Current Stimulation (tDCS) different from other treatments for suicide risk?

Active Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive treatment that uses electrical currents to stimulate specific areas of the brain, which may help improve mood and reduce symptoms of depression. Unlike traditional treatments like medication or talk therapy, tDCS directly targets brain activity and can be administered at home, although safety concerns need to be addressed.1391112

Research Team

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Casey S Gilmore, PhD

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

This trial is for veterans currently in the MVAHCS Inpatient Psychiatric Unit who are at high risk of suicide, either screened positive on the VA's risk evaluation or attempted suicide within the last year. Participants must be able to complete tasks and have a smartphone. Those with seizure history, metal in their head, severe skin conditions on the scalp, involuntary commitment, inability to consent, or significant cognitive impairment cannot join.

Inclusion Criteria

I can complete necessary medical procedures and tasks.
You have a high risk of attempting suicide based on a recent suicide attempt or positive VA Comprehensive Suicide Risk Evaluation (CSRE) screening.
currently admitted into the MVAHCS Inpatient Psychiatric Unit

Exclusion Criteria

have moderate/severe cognitive impairment as determined by the Mini-Mental State Examination (score 27)
do not have a smartphone or device running Android or Apple iOS with which to download the mPRO EMA app
I am able to understand and agree to the study's requirements.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 10 sessions of cognitive training concurrent with either active or sham transcranial direct current stimulation over five days

1 week
10 sessions (in-person)

Follow-up

Participants are monitored for changes in impulsive behavior, executive function, and quality of life

2 months
Follow-up assessments at 1 week, 1 month, and 2 months

Treatment Details

Interventions

  • Active Transcranial Direct Current Stimulation (tDCS)
  • Sham Transcranial Direct Current Stimulation (tDCS)
Trial OverviewThe ENACTS study tests a five-day intervention combining transcranial direct current stimulation (tDCS) with executive function training for veterans at high suicide risk. The goal is to see if this can reduce future suicidal behavior and improve quality of life. Participants will receive either active tDCS or a sham (placebo) version as part of the study.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Participants will receive 10 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).
Group II: Sham tDCSPlacebo Group1 Intervention
Participants will receive 10 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Active Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Transcranial Direct Current Stimulation for:
  • Treatment-resistant depression
  • Chronic pain
  • Cognitive enhancement
  • Research purposes including suicide prevention
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Approved in European Union as Transcranial Direct Current Stimulation for:
  • Treatment-resistant depression
  • Chronic pain
  • Cognitive enhancement
  • Research purposes including neurological and psychiatric conditions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

Transcranial direct current stimulation (tDCS) did not cause cognitive deficits in 243 patients with major depressive disorder over 10 weeks, indicating it is a safe non-pharmacological treatment option.
Patients receiving tDCS showed improved verbal fluency compared to those on placebo, suggesting that tDCS may enhance certain cognitive functions in individuals who respond positively to the treatment.
Cognitive changes after tDCS and escitalopram treatment in major depressive disorder: Results from the placebo-controlled ELECT-TDCS trial.Moreno, ML., Goerigk, SA., Bertola, L., et al.[2022]
Transcranial direct current stimulation (tDCS) effectively targets and modulates depression-related brain areas, specifically the left dorsolateral prefrontal cortex (DLPFC), as confirmed by significant changes in cerebral blood flow and induced magnetic fields during treatment in a study of 66 depressed participants.
High-definition (HD) tDCS showed stronger effects on brain network modulation compared to conventional tDCS, and while both active treatments improved symptoms of anhedonia, there were no significant differences in overall depression scores between the two stimulation methods.
In-vivo imaging of targeting and modulation of depression-relevant circuitry by transcranial direct current stimulation: a randomized clinical trial.Jog, MS., Kim, E., Anderson, C., et al.[2021]
Transcranial direct current stimulation (tDCS) showed significant antidepressant effects in a study of 64 participants with depression, with improved mood after active treatment compared to sham treatment.
While tDCS was generally safe, there was a cautionary note regarding mood switching in individuals with bipolar disorder, as one participant experienced hypomania after treatment.
Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial.Loo, CK., Alonzo, A., Martin, D., et al.[2022]

References

Cognitive changes after tDCS and escitalopram treatment in major depressive disorder: Results from the placebo-controlled ELECT-TDCS trial. [2022]
In-vivo imaging of targeting and modulation of depression-relevant circuitry by transcranial direct current stimulation: a randomized clinical trial. [2021]
Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial. [2022]
The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. [2022]
Transcranial direct current stimulation in the treatment of major depression: a meta-analysis. [2021]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Safety of transcranial direct current stimulation in healthy participants. [2021]
Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]
Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data. [2019]
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]
TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study. [2023]
The Neurostimulation of the Brain in Depression Trial: Protocol for a Randomized Controlled Trial of Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2021]