Magnetic Stimulation of the Brain in Schizophrenia or Depression

NCT02905604 | Completed DMC

• 1 other identifier: MA-SCH-DEP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Depression; Anhedonia; Avolition

Keywords

rTMS; negative symptoms; intermittent theta burst; iTBS; repetitive transcranial magnetic stimulation; dorsomedial prefrontal cortex; dmPFC; NIRS

Outcome Measures

Primary Outcomes (1)

• Mean change of total score on the Clinical Assessment Interview for Negative Symptoms (CAINS).

  From baseline to day after last treatment, i.e. 14-21 days after baseline

Secondary Outcomes (2)

• Mean change of total score on the CAINS

  From baseline to four weeks after baseline.

• Change in Clinical Global Impression (CGI) score

  From baseline to four weeks after baseline.

Study Arms (2)

dmPFC iTBS

EXPERIMENTAL

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

dmPFC Sham iTBS

SHAM COMPARATOR

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

Interventions

dmPFC iTBS DEVICE

2400 pulses/day over 10 week days over bilateral dmPFC using MagPro X100 and the cool D-B80 A/P coil

Also known as: rTMS with intermittent theta-burst frequency

dmPFC iTBS

dmPFC Sham iTBS DEVICE

Sham iTBS

dmPFC Sham iTBS

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of neuroscience, psychiatry, unit for Brain Stimulation and psychiatric clinical trials

Uppsala, 751 85, Sweden

Location

Related Publications (1)

• Malm E, Struckmann W, Persson J, Boden R. Pain trajectories of dorsomedial prefrontal intermittent theta burst stimulation versus sham treatment in depression. BMC Neurol. 2020 Aug 20;20(1):311. doi: 10.1186/s12883-020-01881-3.

  PMID: 32819321 DERIVED

MeSH Terms

Conditions

Schizophrenia; Depression; Anhedonia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Robert Bodén, Ph.D, MD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: September 29, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 20, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)