Auditory Stimulation for Schizophrenia

Overseen By Dara Manoach, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic medications

Disqualifiers: Pregnancy, Neurological disorder, Substance abuse, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia.

Will I have to stop taking my current medications?

The trial does not specify if schizophrenia patients need to stop their current medications. However, healthy controls cannot be on psychotropic medications.

Is auditory stimulation therapy safe for humans?

Research on music therapy, a form of auditory stimulation, shows it is generally safe for people with schizophrenia and can help manage symptoms like anxiety and depression. No significant safety concerns have been reported in the studies reviewed. ^{1 2 3 4 5}

How is auditory stimulation treatment different from other treatments for schizophrenia?

Auditory stimulation treatment for schizophrenia is unique because it uses sound, such as music or radio, to reduce auditory hallucinations by increasing external auditory input, which is different from other treatments like medication or brain stimulation techniques. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Auditory Stimulation for Schizophrenia?

Research shows that music therapy, which is similar to auditory stimulation, can help reduce psychotic symptoms in people with schizophrenia. Studies found that group music activities and listening to music can decrease symptoms like anxiety and improve emotional expression. ^{1 3 9 10 11}

Who Is on the Research Team?

Dara Manoach, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking men and women aged 18-50 who have been diagnosed with schizophrenia. Participants must be outpatients, meaning they aren't currently in the hospital, and able to give informed consent to participate.

Inclusion Criteria

You can speak and understand English well.

I am an outpatient being treated for schizophrenia.

I am either male or female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo two conditions: receiving auditory stimulation during sleep and not receiving auditory stimulation, separated by one week

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auditory Stimulation
• Placebo

Trial Overview The study is examining if playing quiet sounds during sleep (auditory stimulation) can help normalize brain activity and improve memory in people with schizophrenia compared to a placebo (no sound).

How Is the Trial Designed?

Group I: Schizophrenia Experimental Treatment 2 Interventions

Adult outpatients with a diagnosis of schizophrenia.

Group II: Healthy Controls Experimental Treatment 2 Interventions

Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a study involving 67 patients with schizophrenia, group music activity as an adjunctive therapy significantly reduced psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS).

The intervention consisted of 50-minute group music sessions held five times a week for 2 weeks, demonstrating that incorporating music therapy can enhance standard care for patients in acute psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of group music activity as an adjunctive therapy on psychotic symptoms in patients with acute schizophrenia. Peng, SM., Koo, M., Kuo, JC.[2010]

Assisted music therapy combined with drug therapy significantly improved symptoms in chronic schizophrenia patients compared to drug therapy alone, as shown by lower scores on the SANS and BPRS scales in the experimental group.

The study analyzed 11 articles with a total of 603 patients, indicating that while short-term benefits of music therapy are evident, further research is needed to assess its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Meta-analysis of assisted music therapy for chronic schizophrenia]. You, ZY., Wang, JZ.[2006]

Music therapy is well-accepted by schizophrenic patients, showing no negative effects even when introduced during the post-acute phase of treatment, based on a study of 30 patients.

The therapy provides positive benefits such as relaxation, reduced anxiety, and improved emotional expression, although the duration of these effects is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy evaluated by schizophrenic patients]. Reker, T.[2006]

Music therapy, particularly when delivered in a combined format (active and receptive), significantly improves various outcomes for individuals with schizophrenia, including psychotic symptoms, depression, anxiety, and overall quality of life, based on a review of 17 studies.

The dosage of music therapy is crucial, with higher exposure times (ranging from 20 to 9,720 minutes) leading to better results, suggesting that more extended therapy sessions are more effective than shorter ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Dosage and Type of Music Therapy in Symptom Management and Rehabilitation for Individuals with Schizophrenia. Chung, J., Woods-Giscombe, C.[2019]

Transcranial direct current stimulation (tDCS) has shown potential in reducing the severity and frequency of auditory hallucinations in schizophrenia, with three out of six randomized controlled trials reporting therapeutic benefits.

Despite these promising results, the overall evidence is inconclusive and insufficient, as many studies lack large sample sizes, preventing tDCS from being established as a reliable treatment option for auditory hallucinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of transcranial direct current stimulation for the treatment of auditory hallucinations of schizophrenia - a systematic review. Pondé, PH., de Sena, EP., Camprodon, JA., et al.[2020]

Citations

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

Effect of group music activity as an adjunctive therapy on psychotic symptoms in patients with acute schizophrenia. [2010]

2. China pubmed.ncbi.nlm.nih.gov

[Meta-analysis of assisted music therapy for chronic schizophrenia]. [2006]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

[Effects of listening to music on auditory hallucination and psychiatric symptoms in people with schizophrenia]. [2015]

4. Germany pubmed.ncbi.nlm.nih.gov

[Music therapy evaluated by schizophrenic patients]. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Amelioration of psychiatric symptoms through exposure to music individually adapted to brain rhythm disorders - a randomised clinical trial on the basis of fundamental research. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Influence of Dosage and Type of Music Therapy in Symptom Management and Rehabilitation for Individuals with Schizophrenia. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Music Therapy as Treatment of Negative Symptoms for Adult Patients Diagnosed with Schizophrenia-Study Protocol for a Randomized, Controlled and Blinded Study. [2023]

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

Music therapy: harmony for change. [2022]

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

Auditory hallucinations treated by radio headphones. [2004]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Use of transcranial direct current stimulation for the treatment of auditory hallucinations of schizophrenia - a systematic review. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of music listening on P300 event-related potential in patients with schizophrenia: A pilot study. [2022]