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Schizophrenia; PsychosisATMSSlowingNCT06134661

Accelerated rTMS for Psychomotor Slowing

A study testing cTBS (continuous Theta Burst Stimulation) in people with Schizophrenia; Psychosis and Schizophrenia and Related Disorders, run by University of Bern at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
cTBS (continuous Theta Burst Stimulation)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSwitzerland
Study dates
22 Sep 2023to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18-60 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).

Who cannot join

  • 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.
  • Standard exclusion criteria for TMS (implanted electronic devices (e.g. pacemakers, implantable cardioverter-defibrillators, vagus nerve stimulators and wearable cardioverter-defibrillators, ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines even when removed) and/or conductive objects near the coil (e.g. cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments)
Show all 12Show fewer
  • Women who are pregnant or breastfeeding.
  • Any TMS treatment in the past 2 months.
  • If applicable: standard exclusion criteria for MRI (study participation without MRI is possible)
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital of Psychiatry and Psychotherapy

    Bern, 3000

Other trials in Switzerland

About this study

Official title: Optimizing rTMS for Psychomotor Slowing in Psychosis (ATMSSlowing) - A 1-week, Non-randomised Clinical Trial of add-on Accelerated Repetitive Transcranial Magnetic Stimulation for Psychomotor Slowing in Psychosis

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:

Read more

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.

Read the detailed description

Schizophrenia is a chronic disorder causing tremendous burden to the patients, families, and society. Besides prominent symptoms such as hallucinations, delusions, and thought disorder, the majority of patients also experiences motor abnormalities. Converging evidence links aberrant structure and function of the cerebral motor network to schizophrenia pathology, particularly to motor abnormalities. One of the most frequent motor abnormalities is psychomotor slowing (PS), which may impact both gross and fine motor behaviour. While PS causes significant distress and predicts poor outcome, researchers are just starting to understand its pathobiology. First evidence points to aberrant functional and structural connectivity within the cerebral motor network in schizophrenia patients with PS, particularly in connections between premotor/motor cortex and thalamus, as well as between motor cortex and cerebellum. In addition, severe motor inhibition was linked to increased neural activity in the premotor cortex. Repetitive transcranial magnetic stimulation (rTMS) may temporarily alter brain activity.

Data from OCoPS-P (BASEC 2018-02164, clinicaltrials.gov NCT03921450) double-blind RCT indicate that 15 sessions of inhibitory rTMS over three weeks on the supplementary motor area (SMA) alleviate PS.

However, three weeks of one daily rTMS session is rather inconvenient for patients and medical professionals. Therefore, this study will aim to optimize the treatment protocol with regard to efficiency and efficacy by using an accelerated rTMS protocol with continuous theta-burst stimulation (cTBS). Inhibitory cTBS will be applied 3 times per day over 5 days, which will increase the session frequency and shorten sessions and treatment duration.

Reducing the duration of the treatment phase might increase treatment adherence, shorten inpatient treatment, alleviate PS faster, and will facilitate implementation in clinical practice.

Being tested
cTBS (continuous Theta Burst Stimulation)
Keywords
Psychomotor Slowing
Medical subject headings
Schizophrenia, Psychotic Disorders, Psychomotor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cTBS (continuous Theta Burst Stimulation)Device

    Also called TMS (Transcranial Magnetic Stimulation)

    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.

Study groups in NCT06134661
Study groupRoleWhat they receive
Single Arm: Treatment with cTBSExperimentalThis is a single-arm study. All participants will receive the treatment with cTBS.
Receives: Device: cTBS (continuous Theta Burst Stimulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

Secondary outcomes (17)

  1. Change in psychosis severity from baseline

    Change in the Positive And Negative Symptom Scale (PANSS) from baseline, PANSS total score assesses the severity of positive, negative and general symptoms, ranging from 30-210 with higher scores indicating increased symptom severity, i.e. poorer outcome

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

  2. Change in negative symptoms from baseline

    Change in the Brief Negative Symptom Scale (BNSS) from baseline, total score is used, ranging from 0-78 with higher values indicating poorer outcome, i.e. more negative symptom severity

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

  3. Change in catatonia severity from baseline

    Observer based rating of catatonia severity with the Bush Francis Catatonia Rating Scale (BFCRS), total score of the BFCRS ranging 0-69, with higher scores indicating poorer outcome Observer based rating of catatonia severity with the Northoff Catatonia Rating Scale (NCRS), total score ranging 0-80, with higher scores indicating poorer outcome

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

  4. Change in parkinsonism severity from baseline

    Observer based rating of parkinsonism severity with the Unified Parkinson Disease Rating Scale Part III (UPDRS), total score of the UPDRS ranging 0-104, with higher scores indicating poorer outcome

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

  5. Changes in neurological soft signs from baseline

    Observer based rating of neurological soft signs with the Neurological Evaluation Scale (NES), total score ranging 0-82, with higher scores indicating poorer outcome

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

  6. Changes in dyskinesia from baseline

    Observer based rating of dyskinesia with the Abnormal Involuntary Movement Scale (AIMS), 7-item scale with the total ranging fro 0-28, with higher scores indicating poorer outcome

    Measured: At baseline, post at day 5

  7. Changes in self-reported negative symptoms from baseline

    Self-reported negative symptoms with the Self-evaluation of Negative Symptoms (SNS), total score ranging 0-40, with higher scores indicating poorer outcome

    Measured: At baseline, post at day 5

  8. Changes in self-reported catatonia symptoms from baseline

    Self-reported catatonia symptoms with the Northoff Scale for Subjective Experience in Catatonia (NSSC), total score ranging 0-48, with higher scores indicating poorer outcome

    Measured: At baseline, post at day 5

  9. Changes in self-reported activity from baseline

    Change in the International Physical Activity Questionnaire (IPAQ), the total score is used ranging from 0-70000 metabolic equivalent (MET)

    Measured: At baseline, post at day 5

  10. Change in objectively measured physical activity from baseline

    Change in the activity levels using wrist actigraphy from baseline. Actigraphy is measured continuously from baseline to post and a sleep diary is collected to separate wake from sleep hours

    Measured: Continuously from baseline to post at day 5

  11. Change in dexterity from baseline

    Change in the coin rotation task from baseline

    Measured: At baseline, post at day 5

  12. Change in grip strength from baseline

    Change in grip strength measured with a grip force task

    Measured: At baseline, post at day 5

  13. Change in cortical excitability of the motor cortex from baseline

    Changes in motor cortex excitability from beginning of day 1, end of day 1, end of day 3, and end of day 5 using a TMS paradigm of short interval intracortical inhibition (SICI), intracortical facilitation (ICF) and 1 mV motor evoked potentials (MEP).

    Measured: Baseline before the first 3 TMS, baseline after the first 3 TMS, day 3 (after 9 TMS), post at day 5 (after 15 TMS)

  14. Change in social and community functioning

    Change in Social and Occupational Functional Assesment Scale (SOFAS) from baseline, the score ranges from 0-100 with higher scores indicating better functioning, i.e. better outcome

    Measured: Baseline, post at day 5

  15. Change in global functioning

    Change in Global Assessment of Functioning (GAF) from baseline, total score ranging 0-100 with higher scores indicating better functioning/outcome

    Measured: Baseline, post at day 5

  16. Change in functional capacity

    Change in the Score of the brief version of the University of California, San Diego, Performance-Based Skills Assessment (UPSA-brief) assessment from baseline, higher scores indicating better function, the total score is used ranging 0-100

    Measured: Baseline, post at day 5

  17. Change in DSM 5 Severity Scale of Dimensions

    Change in expert rated DMS 5 Severity Scale of Dimensions from baseline. Eight symptom dimensions are rated from 0 to 4 (total 0-32), with higher scores indicating worse outcomes

    Measured: Baseline, post at day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start22 Sep 2023
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Why it stopped: Planned interim analyses demonstrated that the main aim of the study was already met. Recruitment was stopped. Early termination was unrelated to safety.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134661
Sponsor's protocol ID
ATMSSlowing
Acronym
ATMSSlowing
Status last verified
Sep 2024
First submitted
23 Oct 2023
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing cTBS (continuous Theta Burst Stimulation) in people with Schizophrenia; Psychosis and Schizophrenia and Related Disorders, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Planned interim analyses demonstrated that the main aim of the study was already met. Recruitment was stopped. Early termination was unrelated to safety.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Salpetriere Retardation Rating Scale (SSRS) from baseline (time frame: At baseline, day 3, post at day 5, and follow-up 1 week later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06134661.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.

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