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Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia

ConditionsSchizophreniaSchizo Affective Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMclean Hospital

About this trial

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of schizophrenia or schizoaffective disorder

Disqualifiers

substance use disorder in past 3 months

ambidexterity

history of neurological disorder

history of head trauma resulting in loss of consciousness

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

    Device

    rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry. The rTMS pulses will be delivered in a pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz every 10s for 600 total pulses.

  • Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

    Device

    rTMS is a technique of TMS that allows for selective external manipulation of neural activity in a non-invasive manner. During rTMS a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field, which in turn induces electrical current in neurons and allows for modulation of neural circuitry. The rTMS pulses will be delivered in a pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz every 10s for 600 total pulses. Sham is achieved by using a coil with a magnetic shield preventing magnetic field from reaching the head.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Active cerebellum rTMSActive comparator 1 intervention
Group B: Sham cerebellum rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

functional connectivity

change in functional connectivity of a putative cerebellar-thalamic-cortical hallucination circuit (cerebellum to thalamus) will be assessed before and after (1 week followup) TMS stimulation.

Time frame
baseline, 1 week after TMS
2

Positive and Negative Syndrome Scale (PANSS)

The PANSS is clinical rating scale of symptom severity . Each descriptor is rated on a 7 point scale from 1=(absence of any symptom) to 7=(extremely severe symptoms).

Time frame
baseline
3

Scale for the Assessment of Positive Symptoms (SAPS)

The SAPS is clinical rating scale of symptom severity . Each descriptor is rated on a 5 point scale from 1=(absence of any symptom) to 5=(extremely severe symptoms).

Time frame
baseline
4

Auditory Hallucination Rating Scale (AHRS) Scale (AHRS)

The AHRS is a 7-item clinical rating scale used to assess auditory hallucinations.

Time frame
baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

Beth Israel Deaconess Medical Center

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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