Transcranial Electrical Stimulation for Hallucinations

Overseen By Paulo Lizano, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Substance abuse, Pregnancy, Head injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 1 week

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a technique that applies a weak electrical current to the scalp to help patients with psychotic disorders who experience hallucinations. The treatment targets a specific brain area involved in processing sensory information to reduce abnormal activity and alleviate hallucinations. This non-invasive brain stimulation technique enhances the precision of the treatment by using smaller electrodes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Transcranial Electrical Stimulation for Hallucinations?

Research shows that transcranial direct current stimulation (tDCS), a type of transcranial electrical stimulation, can help reduce persistent auditory hallucinations in people with schizophrenia, especially when other medications don't work. Studies have found that tDCS is safe and can improve symptoms when used as an additional treatment. ^{1 2 3 4 5}

Is transcranial electrical stimulation safe for humans?

Transcranial electrical stimulation, including tDCS, tACS, and tRNS, is generally considered safe for humans, with no serious adverse events reported in over 18,000 sessions. Mild side effects like headaches and skin sensations are common, but serious issues are rare, and safety is well-established for low-intensity use. ^{6 7 8 9 10}

How does transcranial electrical stimulation differ from other treatments for hallucinations?

Transcranial electrical stimulation (TES) is unique because it is a noninvasive brain stimulation technique that uses electrical currents to modulate brain activity, unlike traditional drug treatments. It includes methods like transcranial direct current stimulation (tDCS) and transcranial random noise stimulation (tRNS), which have shown promise in reducing auditory hallucinations in schizophrenia, especially when other treatments have failed. ^{1 4 5 10 11}

Research Team

Paulo Lizano, MD PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for English-speaking adults aged 18-50 who are currently experiencing hallucinations. It's not suitable for those with recent substance abuse, pregnant or breastfeeding individuals, people with significant head injuries, intellectual disabilities, metal implants in the body (especially in the head), or a history of seizures.

Inclusion Criteria

I am currently experiencing hallucinations.

Proficient in English

Able to give informed consent

Exclusion Criteria

You have an intellectual disability according to the DSM-V guidelines.

I have a history of seizures.

You have metal in your body that cannot be taken out, especially near your head.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active tDCS or sham stimulation to the rSTS for 5 days, with two 20-minute sessions each day

1 week

10 visits (in-person)

Follow-up

Participants are monitored for changes in psychosis symptoms and other outcomes

1 month

Treatment Details

Interventions

• Transcranial Electrical Stimulation

Trial Overview The study tests Transcranial Electrical Stimulation (tES) targeted at the right superior temporal sulcus (rSTS) to see if it can improve brain activity and reduce hallucinations in psychotic disorders like schizophrenia.

Participant Groups

Group I: Active Stimulation with TDCS Experimental Treatment 1 Intervention

10 tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).

Group II: SHAM Stimulation Placebo Group 1 Intervention

10 passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).

Transcranial Electrical Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Electrical Stimulation for:

• Depression
• Anxiety
• Chronic Pain
• Stroke Rehabilitation
• Research Use for Various Conditions Including Hallucinations

Approved in European Union as Transcranial Electrical Stimulation for:

• Depression
• Chronic Pain
• Stroke Rehabilitation
• Research Use for Various Conditions Including Hallucinations

Approved in Canada as Transcranial Electrical Stimulation for:

• Depression
• Chronic Pain
• Research Use for Various Conditions Including Hallucinations

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Findings from Research

Transcranial direct-current stimulation (tDCS) significantly reduced the severity of auditory verbal hallucinations in 30 patients with schizophrenia, showing a mean reduction of 31% compared to sham stimulation, with effects lasting up to 3 months.

tDCS also improved other symptoms of schizophrenia, particularly negative and positive symptoms, indicating its potential as a treatment for medication-refractory cases, despite the study's small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Brunelin, J., Mondino, M., Gassab, L., et al.[2022]

Transcranial direct current stimulation (tDCS) may be an effective treatment for patients with schizophrenia who experience severe auditory hallucinations that do not respond to traditional antipsychotic medications, based on evidence from a well-conducted randomized trial and several case reports.

tDCS has been safely administered at current intensities of 1-3 mA for 20-30 minutes in once- to twice-daily sessions for up to 3 years, showing no apparent adverse effects, making it a promising noninvasive option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for refractory auditory hallucinations in schizophrenia. Andrade, C.[2013]

A meta-analysis of 8 randomized controlled trials involving 329 schizophrenia patients found that active transcranial direct current stimulation (tDCS) did not show a significant overall advantage over sham stimulation for reducing auditory hallucinations.

However, when tDCS was administered twice daily or for 10 or more sessions, it demonstrated a significant improvement in auditory hallucination symptoms, suggesting that specific treatment parameters are crucial for efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive tDCS for treatment-refractory auditory hallucinations in schizophrenia: A meta-analysis of randomized, double-blinded, sham-controlled studies. Jiang, WL., Cai, DB., Sun, CH., et al.[2022]

Transcranial direct current stimulation (tDCS) is a safe and noninvasive method that has been shown to effectively reduce persistent auditory hallucinations in patients with schizophrenia.

The study highlights that tDCS has a differential impact on auditory hallucinations compared to other positive symptoms of schizophrenia, particularly in patients who exhibit heightened attention to their hallucinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right-sided Transcranial Direct Current Stimulation and Attentional Salience of Auditory Hallucinations in Schizophrenia. Dinakaran, D., Parlikar, R., Sreeraj, VS., et al.[2020]

In a study involving 19 schizophrenia patients, add-on High-Definition transcranial Direct Current Stimulation (HD-tDCS) significantly reduced persistent auditory hallucinations after 5 days of treatment, indicating its potential efficacy as a therapeutic intervention.

The use of a 2-mA cathodal current on the left temporo-parietal junction suggests that HD-tDCS may offer more targeted neuromodulation compared to conventional tDCS, warranting further research into its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-definition transcranial direct current simulation (HD-tDCS) for persistent auditory hallucinations in schizophrenia. Sreeraj, VS., Dinakaran, D., Parlikar, R., et al.[2019]

In a study involving 1,019 participants across 4 sites, adverse events (AEs) following multiple sessions of transcranial electrical stimulation (tES) were found to be influenced more by factors like testing site and session number rather than the stimulation itself, suggesting a good safety profile for repeated use.

The effectiveness of blinding procedures was found to be less reliable for tDCS and tACS compared to tRNS, indicating a need for improved blinding methods, especially when using higher stimulation intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation. Sheffield, JG., Ramerpresad, S., Brem, AK., et al.[2022]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) is a non-invasive treatment that has been suggested as a safe option for reducing auditory hallucinations in patients with schizophrenia, but the evidence is currently limited.

A systematic review of three studies involving 87 patients found inconsistent results and a low overall level of evidence, indicating that more high-quality research with larger sample sizes is necessary to determine the true efficacy of tDCS for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Transcranial Direct Current Stimulation (tDCS) for Auditory Hallucinations: A Systematic Review. Li, H., Wang, Y., Jiang, J., et al.[2020]

In a preliminary study of ten patients with treatment-resistant schizophrenia, high-frequency transcranial random noise stimulation (hf-tRNS) significantly reduced auditory hallucinations by an average of 36.1%, indicating its potential efficacy as a noninvasive treatment.

The study involved 10 sessions of hf-tRNS targeting specific brain areas, suggesting that this method may offer a promising alternative to conventional treatments, although further sham-controlled studies are necessary to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency Transcranial Random Noise Stimulation for Auditory Hallucinations of Schizophrenia: A Case Series. Mondino, M., Janin, D., Galvao, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for refractory auditory hallucinations in schizophrenia. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adjunctive tDCS for treatment-refractory auditory hallucinations in schizophrenia: A meta-analysis of randomized, double-blinded, sham-controlled studies. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Right-sided Transcranial Direct Current Stimulation and Attentional Salience of Auditory Hallucinations in Schizophrenia. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

High-definition transcranial direct current simulation (HD-tDCS) for persistent auditory hallucinations in schizophrenia. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

10. China pubmed.ncbi.nlm.nih.gov

Effects of Transcranial Direct Current Stimulation (tDCS) for Auditory Hallucinations: A Systematic Review. [2020]

11. Switzerland pubmed.ncbi.nlm.nih.gov

High-Frequency Transcranial Random Noise Stimulation for Auditory Hallucinations of Schizophrenia: A Case Series. [2023]