Overcoming Psychomotor Slowing in Psychosis (OCoPS-P)

NCT03921450 | Completed

• 1 other identifier: 2018-02164
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Psychomotor slowing is a major problem in psychosis. Aberrant function of the cerebral motor system is linked to psychomotor slowing in patients, particularly resting state hyperactivity in premotor cortices. A previous clinical trial indicated that inhibitory stimulation of the premotor cortex would reduce psychomotor slowing. The current study is further exploring this effect in a randomized, placebo-controlled, double-blind design with three arms of transcranial magnetic stimulation and measures of brain imaging and physiology prior to and after the intervention.

Conditions

Schizophrenia and Related Disorders; Schizophrenia; Schizoaffective Disorder; Brief Psychotic Disorder

Keywords

motor behavior; psychomotor slowing; psychosis

Outcome Measures

Primary Outcomes (2)

• Proportion of responders at week 3

  Proportion of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale (SRRS)

  Week 3

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

  Change in the Salpetriere Retardation Rating Scale (SRRS) from baseline; the total score of 15 items is used, ranging 0-60 with higher scores indicating worse outcome

  Week 3, week 6, week 24

Secondary Outcomes (11)

• Change in catatonia severity from baseline to week 3

  Week 3, week 6, week 24

• Change in negative symptoms from baseline

  Week 3, week 6, week 24

• Change in psychosis severity from baseline

  Week 3, week 6, week 24

• Change in physical activity self report from baseline

  Week 3, week 6, week 24

• Change in objectively measured physical activity from baseline

  Week 3, week 6, week 24

Study Arms (4)

Inhibitory repetitive transcranial magnetic stimulation (rTMS)

EXPERIMENTAL

1 Hz stimulation of 17 mins over the supplementary motor area (SMA), 1000 pulses at 110% resting motor threshold intensity total of 15 sessions in 3 weeks

Device: 1 Hz rTMS

Facilitatory intermittent theta burst stimulation (iTBS)

ACTIVE COMPARATOR

Intermittent theta burst stimulation of 50 Hz over the supplementary motor area (SMA) with 600 pulses in 2 sec trains every 10 seconds for 190 seconds total. Two iTBS stimulations will be administered with 15 mins pause in between. total of 15 sessions in 3 weeks

Device: iTBS

Placebo

PLACEBO COMPARATOR

1 Hz stimulation of 17 mins over the supplementary motor area (SMA) without any magnetic emission using a placebo-coil that looks identical and makes identical sounds as the real TMS coil total of 15 sessions in 3 weeks

Drug: Placebo

Waiting group

NO INTERVENTION

This group will receive no intervention for 3 weeks. Afterwards they will receive the inhibitory rTMS protocol as in the first arm

Interventions

1 Hz rTMS DEVICE

1 Hz stimulation at 110% of resting motor threshold over supplementary motor area

Inhibitory repetitive transcranial magnetic stimulation (rTMS)

iTBS DEVICE

50 Hz theta burst stimulation at 80% of resting motor threshold over supplementary motor area

Facilitatory intermittent theta burst stimulation (iTBS)

Placebo DRUG

1 Hz stimulation with the placebo TMS coil without any magnetic emission

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handed subjects
• Ability and willingness to participate in the study
• Ability to provide written informed consent
• Informed Consent as documented by signature
• Schizophrenia spectrum disorder according to diagnostic and statistical manual version 5 (DSM-5) criteria with current psychomotor slowing according to the Salpetriere Retardation Rating Scale (SRRS), score \>= 15

You may not qualify if:

• Substance abuse or dependence other than nicotine
• Past or current medical or neurological condition associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia, or severe head trauma with subsequent loss of consciousness.
• Epilepsy or other convulsions
• History of any hearing problems or ringing in the ears
• Patients only: any TMS treatment in the past 3 months
• Women who are pregnant or breast feeding,
• Intention to become pregnant during the course of the study,
• Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Controls only: history of any psychiatric disorder or first-degree relatives with schizophrenia spectrum disorders.

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Hospital of Psychiatry

Bern, 3000, Switzerland

Location

Related Publications (1)

• Walther S, Alexaki D, Weiss F, Baumann-Gama D, Kyrou A, Nuoffer MG, Wuthrich F, Lefebvre S, Nadesalingam N. Psychomotor Slowing in Psychosis and Inhibitory Repetitive Transcranial Magnetic Stimulation: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Jun 1;81(6):563-571. doi: 10.1001/jamapsychiatry.2024.0026.

  PMID: 38416468 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Motor Activity; Psychomotor Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Sebastian Walther, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will not know the stimulation protocol, neither will the outcome assessor or the mental health care provider know the protocol applied
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 week intervention with 15 sessions of add-on rTMS in 4 parallel arms, randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: March 25, 2019
• Primary Completion: November 1, 2022
• Study Completion: February 10, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)