Magnetic Stimulation of the Brain in Schizophrenia or Depression (MA-SCH-DEP)

April 28, 2020 updated by: Uppsala University

Magnetic Stimulation of the Brain in Schizophrenia or Depression: A Randomized, Double Blind, Sham Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Schizophrenia or Depression

The primary objective is to evaluate if repetitive transcranial magnetic stimulation (rTMS) with theta burst frequency over dorsomedial prefrontal cortex (DMPFC) is an effective treatment for negative symptoms (anhedonia and avolition) in schizophrenia or depression. Other objectives are to increase the understanding of the underlying neurobiology of negative symptoms and the mechanisms for the treatment effect of rTMS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double blind parallel randomized sham controlled trial. The intervention is intermittent theta-burst stimulation (iTBS), which is rTMS with theta burst frequency with 2400 pulses/day in two sessions at 90% of resting motor threshold intensity over the DMPFC, given in ten days on week days (10 treatment days must be completed within a maximum of 21 days). Stratified (depression and schizophrenia diagnosis) block randomization will be used for treatment allocation to active or sham side of the stimulation coil.

Patients will be referred from their regular psychiatric care facilities. At the screening visit the patient will be assessed if fulfilling all inclusion and none of the exclusion criteria. At the baseline visit thorough psychiatric, cognitive and neurophysiological examination will be performed. The latter include investigation of cortical excitability with paired-pulse TMS, mismatch negativity (MMN, a measure of aberrant stimulus detection), startle-response, habituation, electrodermal activity (EDA), near-infrared spectroscopy (NIRS), 24 hour actigraphy and heart rate registration.

During 10 week days the participants will receive a daily rTMS (or sham) treatment. On the day after last rTMS treatment the examinations performed at the baseline visit will be repeated. Four weeks after baseline there is a shorter visit to follow-up symptoms and functioning. At the end of this visit the blinding is unmasked and patients who have received sham rTMS will be offered active treatment in an open-phase. After the four weeks follow-up there are two additional and identical visits at 10 and 26 weeks after start of treatment.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 85
        • Department of neuroscience, psychiatry, unit for Brain Stimulation and psychiatric clinical trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of schizophrenia spectrum disorders or uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
  • negative symptoms with anhedonia and avolition: ≤40 points on the The Motivation and Pleasure Scale-Self-Report (MAP-SR)
  • unchanged medication the past month
  • provision of signed informed consent form

Exclusion Criteria:

  • epilepsy
  • conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil
  • implanted device that is activated or controlled in any way by physiological signals
  • implanted mediation pumps
  • intracardiac lines, even when removed
  • addiction (illicit drugs or alcohol) and pregnancy
  • any condition that seriously increases the risk of non-compliance or loss of follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dmPFC iTBS
Repetitive transcranial magnet stimulation (rTMS) over the dorsomedial prefrontal cortices at 90% of the resting motor threshold of the foot flexors. The rTMS is given in 20 trains to the left and right dmPFC, respectively. Each train consists of 10 bursts at 5 Hz (theta-frequency), and each burst consists of 3 pulses at 50 Hz. The stimulation is intermittent with 2 seconds of stimulation, 8 seconds off. After a 15 minute break the whole protocol i applied again, resulting in 2400 pulses/day. Treatment is delivered daily at 10 week days.
Device: dmPFC iTBS
2400 pulses/day over 10 week days over bilateral dmPFC using MagPro X100 and the cool D-B80 A/P coil
Other Names:
  • rTMS with intermittent theta-burst frequency
Sham Comparator: dmPFC Sham iTBS
A sham treatment protocol by using a sham coil with two identical sides where one side give active treatment as described above while on the other side the coil is insulated so very little magnetic energy is delivered. The coil has a built in positioning sensors and a software handling the randomization codes prompts the operator which side of the coil that should be directed towards the patient. Superficial transcutaneous electrical nerve stimulation (TENS) is applied over the stimulation site of the dmPFC synchronous wiht the TMS pulses to further mimic the sensation of the active stimulation.
Device: dmPFC Sham iTBS
Sham iTBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change of total score on the Clinical Assessment Interview for Negative Symptoms (CAINS).
Time Frame: From baseline to day after last treatment, i.e. 14-21 days after baseline
From baseline to day after last treatment, i.e. 14-21 days after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change of total score on the CAINS
Time Frame: From baseline to four weeks after baseline.
From baseline to four weeks after baseline.
Change in Clinical Global Impression (CGI) score
Time Frame: From baseline to four weeks after baseline.
From baseline to four weeks after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Robert Bodén, Ph.D, MD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2016

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

January 20, 2020

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-SCH-DEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information comments: Updated investigational plan can be requested from the Swedish medical products agency

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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