NCT02204787

Brief Summary

The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2018

Completed
Last Updated

December 14, 2022

Status Verified

November 1, 2017

Enrollment Period

4.6 years

First QC Date

July 29, 2014

Last Update Submit

December 13, 2022

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Scale for the Assessment of Negative Symptoms

    up to 3 months after intervention

Study Arms (2)

active tDCS

EXPERIMENTAL

Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.

Device: transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a sham stimulation during 20 minutes. Initial stimulation followed by turning off the device as to ensure blinding.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulationDEVICE
Sham tDCSactive tDCS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia with prominent negative symptoms

You may not qualify if:

  • other psychiatric or neurological diseases
  • specific tDCS limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Jerome ATTAL, MD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 30, 2014

Study Start

April 1, 2014

Primary Completion

October 26, 2018

Study Completion

October 26, 2018

Last Updated

December 14, 2022

Record last verified: 2017-11

Locations

FR(1)