Accelerated rTMS for Psychomotor Slowing

NCT06134661 | Terminated

• 1 other identifier: ATMSSlowing
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to optimize the treatment of psychomotor slowing in patients with schizophrenia using Transcranial Magnetic Stimulation (TMS). A previous randomized controlled trial indicated that inhibitory stimulation over the supplementary motor area (SMA) once daily over 3 weeks ameliorates psychomotor slowing. In this trial the investigators use a shorter inhibitory protocol called cTBS and to be applied 3 times per day. This should lead to faster treatment response and less burden to patients. The main question the investigators aim to answer are: Can the treatment with cTBS 3 times per day ameliorate psychomotor slowing in schizophrenia over one week? Participants will complete questionnaires on the first and last day of the study. Each day, participants will receive the TMS-treatment. Optionally, participants can receive a cerebral MRI before the study and/or come for an additional day 6 to repeat some of the questionnaires. There is no comparison group. All participants will receive the same treatment.

Conditions

Schizophrenia; Psychosis; Schizophrenia and Related Disorders; Schizo Affective Disorder; Brief Psychotic Disorder

Keywords

Psychomotor Slowing

Outcome Measures

Primary Outcomes (2)

• Change in Salpetriere Retardation Rating Scale (SSRS) from baseline

  Changes in psychomotor slowing as measured by the Salpêtrière retardation rating scale (SRRS) throughout the study. The SRRS is a 15-item rating scale that measures psychomotor slowing. Each item can be scored from 0 to 4, thus the total ranging from 0 to 60, with lower scores representing better outcome.

  At baseline, day 3, post at day 5, and follow-up 1 week later

• Proportion of responders in SRRS

  Proportion of responders (\>= 30% reduction from baseline SRRS) at day 3 and day 5. This will provide an additional categorical measure of who benefits from the intervention in terms of the main target (psychomotor slowing).

  At baseline, day 3, post at day 5, and follow-up 1 week later

Secondary Outcomes (17)

• Change in psychosis severity from baseline

  At baseline, post at day 5, and follow-up 1 week later

• Change in negative symptoms from baseline

  At baseline, post at day 5, and follow-up 1 week later

• Change in catatonia severity from baseline

  At baseline, day 3, post at day 5, and follow-up 1 week later

• Change in parkinsonism severity from baseline

  At baseline, day 3, post at day 5, and follow-up 1 week later

• Changes in neurological soft signs from baseline

  At baseline, post at day 5, and follow-up 1 week later

Other Outcomes (8)

• Incidence of Treatment-Emergent Adverse Events as assessed by a safety questionnaire

  Daily between baseline and post at day 5

• Incidence of spontaneously mentioned Treatment-Emergent Adverse Events

  Daily between baseline and post at day 5, and follow-up 1 week later

• Resting-state functional connectivity as a Biomarker of the severity of PS

  In the week before baseline

Study Arms (1)

Single Arm: Treatment with cTBS

EXPERIMENTAL

This is a single-arm study. All participants will receive the treatment with cTBS.

Device: cTBS (continuous Theta Burst Stimulation)

Interventions

cTBS (continuous Theta Burst Stimulation) DEVICE

Continuous Theta Burst Stimulation (cTBS) is an inhibitory stimulation protocol of the Transcranial Magnetic Stimulation (TMS) device that temporarily inhibits brain activation in a small targeted brain area. The investigators apply the cTBS protocol 3 times daily at 100% of the resting motor threshold (RMT) for 1500 pulses per session.

Also known as: TMS (Transcranial Magnetic Stimulation)

Single Arm: Treatment with cTBS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years.
• Ability and willingness to participate in the study
• Ability to provide written informed consent
• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Schizophrenia spectrum disorders according to DSM-5 with psychomotor slowing (SRRS score ≥ 15).

You may not qualify if:

• Substance abuse or dependence other than nicotine.
• Past or current medical or neurological conditions associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia.
• Severe head trauma with subsequent loss of consciousness.
• Epilepsy or other convulsions.
• History of any hearing problems or ringing in the ears.
• Women who are pregnant or breastfeeding.
• Any TMS treatment in the past 2 months.
• Intention to become pregnant during the course of the study
• Previous enrolment into the current study
• Enrolment of the investigator, his/her family members, employees, and other dependent persons

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Hospital of Psychiatry and Psychotherapy

Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Psychomotor Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Sebastian Walther, Prof. Dr. med

  Translational Research Center, University Hospital of Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 18, 2023
• Study Start: September 22, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)