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Clinical Trials/NCT01373866
NCT01373866CompletedNot Applicable

Multimodal MRI-guided Repetitive Transcranial Magnetic Stimulation to Treat Drug-resistant Hallucinations: a Randomized Control Trial

University Hospital, Lille4 sites in 1 country85 target enrollmentStarted: November 15, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
85
Locations
4
Primary Endpoint
Severity and Frequency of Hallucinations
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

  • The efficacy of neuro-navigated rTMS for patients with schizophrenia suffering from drug-resistant multisensory hallucinations will be tested by the implementation of a double-blind randomized controlled trial (RCT)
  • This study will use a combination of different MRI modalities (fMRI and DTI) to define with precision rTMS brain-targets in the case of multisensory hallucinations
  • The investigators anticipate that multimodal MRI-guided rTMS will allow a significant improvement in the efficacy of neuromodulation treatment of refractory hallucinations

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
13 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Right-handed Female/Male, [13-60 y.o.],
  • •Schizophrenia (DSM-IV-TR diagnosis),
  • •Drug-resistant hallucinations (Kinon & Kane criteria, 1993),
  • •Unmodified antipsychotic dosage during the 30 days preceding rMTS,
  • •No anticonvulsive medication,
  • •No neurological disorder, no addictive behavior,
  • •Matched for sex, age and PANSS scores,
  • •Consent to participate to the study,

Exclusion Criteria

  • •Pregnancy
  • •Contraindication to MRI scan
  • •Contraindication to rTMS treatment
  • •Claustrophobia
  • •No social insurance

Outcomes

Primary Outcomes

Severity and Frequency of Hallucinations

Time Frame: Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12)

Visual Analogue Scale (Severity)/ Visual Analogue Scale (Frequency rate)

Secondary Outcomes

  • MRI changes(Assessed at baseline (t0) and 1 month after the rTMS sessions (M+1))
  • Clinical State(Assessed at baseline (t0) and longitudinally after the 10 rTMS sessions during the following month (D+15, M+1, M+3, M+6, M+12))

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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