N/A
N=26
Targeting Cerebellum to Treat Psychosis: a Transcranial Magnetic Stimulation (TMS) Study
Schizophrenia · Schizoaffective Disorder · Bipolar Disorder I
Bottom Line
View on ClinicalTrials.gov: NCT02642029 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Change (Δ) in Accuracy of Time Interval Discrimination Pre- and Post-TMS — .503; .521; .456; .479 accuracy (proportion correct) — p=0.51
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Excitatory TMS (Device); Inhibitory TMS (Device); Sham TMS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change (Δ) in Accuracy of Time Interval Discrimination Pre- and Post-TMS |
.503; .521; .456; .479; .514; .525 | 0.51 |
| PRIMARY Change (Δ) in Accuracy of N-back Working Memory Task Pre- and Post-TMS |
0.780; 0.753; 0.775; 0.795; 0.778; 0.784 | .626 |
| PRIMARY Change (Δ) in Reaction Time (RT) of N-back Working Memory Task Pre- and Post-TMS |
831; 862; 901; 817; 886; 877 | 0.1118 |
| PRIMARY Change (Δ) in Symptoms (Depressed Mood) |
22.5; 37; 16; 19.5; 42; 4 | 0.910 |
| PRIMARY Change (Δ) in Symptoms (Anxiety) |
22; 50; 23; 4; 30; 5 | 0.830 |
| PRIMARY Change (Δ) in Symptoms (Elated Mood) |
6; 2; 1; 8.5; 0; 1 | 0.755 |
| PRIMARY Change (Δ) in Symptoms (Auditory Hallucinations) |
0; 0; 0; 0; 0; 0 | .035 sig |
| PRIMARY Change (Δ) in Symptoms (Visual Hallucinations) |
0; 0; 0; 0; 0; 0 | .748 |
| PRIMARY Change (Δ) in Symptoms (Paranoid Ideation) |
0; 0; 0; 0; 0; 0 | .020 sig |
| PRIMARY Change (Δ) in Symptoms (Ideas/Delusions of Reference) |
0; 0; 0; 0; 0; 0 | .237 |
| PRIMARY Change (Δ) in Symptoms (Delusions of Control) |
0; 0; 0; 0; 0; 0 | .330 |
Summary
The goal of this study is to use transcranial magnetic stimulation (TMS) to investigate the impact of modulating cerebellar activity on time perception, executive function, and mood and psychotic symptoms in psychosis patients (i.e., schizophrenia, schizoaffective disorder, and bipolar disorder with psychotic features). The investigators hypothesize that abnormally reduced activity in the cerebellum contributes to the abnormalities in patients, that cerebellum-mediated disruptions in time perception may partially underlie executive dysfunction and symptoms, and that cerebellar stimulation will normalize disease-relevant outcome measures.
Eligibility Criteria
Inclusion Criteria
- Patients
- Men and women
- Ages 18-50 years
- Patients diagnosed with schizophrenia (SZ), schizoaffective disorder (SZA), or psychotic bipolar disorder (BP).
- On a stable psychiatric medication regimen for at least a month prior to and during study participation
- Healthy Controls:
- Men and women
- Ages 18-50 years
- Without major psychiatric illness
Exclusion Criteria
- Patients
- Any change in psychiatric medications within a month prior to and during study participation
- Legal or mental incompetency
- Intellectual disability
- Substance use disorder (abuse or dependence) with active use within the last 3 months
- Significant medical or neurological illness
- Prior neurosurgical procedure
- History of seizures
- History of electroconvulsive therapy (ECT) or clinical TMS within the past three months
- History of participation in a cerebellar TMS study
- Implanted cardiac pacemakers
- Patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or neck, or are non-removable and within 30 cm of the treatment coil. These include:
- Aneurysm clips or coils
- Carotid or cerebral stents
- Metallic devices implanted in the head (e.g. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt)
- Magnetically active dental implants
- Cochlear/otologic implants
- CSF shunts
- Ferromagnetic ocular implants
- Pellets, bullets, fragments less than 30 cm from the coil
- Facial tattoos with metallic ink, permanent makeup less than 30 cm from the coil
- Pregnant women
- Healthy Controls:
- History of major psychiatric illness, including psychosis
- Has a first-degree relative with psychosis
- Active use of psychotropic medications
- Legal or mental incompetency
- Intellectual disability
- Substance use disorder (abuse or dependence) with active use within the last 3 months
- Significant medical or neurological illness
- Prior neurosurgical procedure
- History of seizures
- History of ECT treatment or clinical TMS within the past three months
- History of participation in a cerebellar TMS study
- Implanted cardiac pacemakers
- Individuals who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or neck, or are non-removable and within 30 cm of the treatment coil. These include:
- Aneurysm clips or coils
- Carotid or cerebral stents
- Metallic devices implanted in the head (e.g. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, transcutaneous electrical nerve stimulation (TENS) unit, or ventriculo-peritoneal shunt)
- Magnetically active dental implants
- Cochlear/otologic implants
- Cerebrospinal fluid (CSF) shunts
- Ferromagnetic ocular implants
- Pellets, bullets, fragments less than 30 cm from the coil
- Facial tattoos with metallic ink, permanent makeup less than 30 cm from the coil
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02642029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.