Phase 2
N=85
Transcranial Magnetic Stimulation for "Voices"
Schizophrenia · Hallucinations
Bottom Line
View on ClinicalTrials.gov: NCT00308997 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Hallucination Change Score - Right (HCS-right) — 7.78; 9.30 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 1-hertz Repetitive Transcranial Magnetic Stimulation (Device); Active 1-Hertz Repetitive transcranial magnetic stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hallucination Change Score - Right (HCS-right) |
7.78; 9.30 | — |
| PRIMARY Hallucination Change Score - Left (HCS-left) |
8.65; 8.50 | — |
| PRIMARY Hallucination Change Score (HCS) |
6.45; 7.51 | — |
| SECONDARY Change in Hallucination Frequency |
1.31; 0.30 | — |
| SECONDARY Change in Total Auditory Hall Rating Scale (AHRS) Score |
4.48; 3.0 | — |
| SECONDARY Clinical Global Improvement (CGI)Improvement |
2.72; 3.21 | — |
Summary
This study will determine the efficacy of MRI-guided transcranial magnetic stimulation (TMS)in reducing "voices" and other symptoms experienced by people with schizophrenia and schizoaffective disorder. In addition, the study will determine duration of improvement obtained during the course of trial participation via on-going monthly contact with study participants for up to 1 year after the trial.
Eligibility Criteria
Inclusion Criteria
- Auditory hallucinations that occur at least five times per day, on average
- Diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria
- Pregnant
- History of seizure that is not drug-induced or secondary to alcohol withdrawal
- Drug or alcohol abuse within 6 weeks of study entry (prior history of drug or alcohol abuse is not an exclusion)
- Changes in antipsychotic drug dosages within 4 weeks of study entry (patients do not need to be on antipsychotic medication to be included)
- Current significant untreated or unstable medical illness (e.g., poorly controlled diabetes mellitus, severe hypertension, unstable cardiac arrhythmia)
- Inability to understand the nature of the study due to severe psychotic disorganization, mental retardation, etc.
- Significant neurological condition (e.g., traumatic brain injury, multiple sclerosis)
- Factors that would preclude an MRI scan (e.g., severe obesity, claustrophobia, certain surgical implants with metallic components, metal shavings in the eye acquired while working as machinist)
- Cardiac pacemaker
Data sourced from ClinicalTrials.gov (NCT00308997). 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.