NCT03275766

Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders

Completed NA Results posted Last updated 12 May 2021

What this trial tests

NA trial testing DLPFC facilitatory in Psychomotor Retardation in 45 participants. Completed in 15 July 2019.

Timeline

1 June 2016

Primary endpoint
1 July 2019

15 July 2019

Quick facts

Lead sponsor	University of Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	45
Start date	1 June 2016
Primary completion	1 July 2019
Estimated completion	15 July 2019
Sites	1 location across Switzerland

Drugs / interventions tested

• DLPFC facilitatory
• SMA inhibitory
• SMA facilitatory
• sham TMS

Conditions studied

• Psychomotor Retardation — all drugs for Psychomotor Retardation →
• Psychomotor Slowing — all drugs for Psychomotor Slowing →
• Schizophrenia and Related Disorders — all drugs for Schizophrenia and Related Disorders →
• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

University of Bern

Who can join

Adults 18 to 65, any sex, with Psychomotor Retardation or Psychomotor Slowing. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Responders at Week 3 Primary · week 3

Number of participants with \>30% reduction from baseline in the Salpetriere Retardation Rating Scale, last observation carried forward method applied

Group	Value	95% CI
DLPFC Facilitatory	4
preSMA/SMA Inhibitory	9
preSMA/SMA Facilitatory	0
Sham TMS	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected during and after the daily rTMS sessions, inquiry covered the total three weeks of the trial. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DLPFC Facilitatory

Serious: 0/12 (0%)

Deaths: 0/12

preSMA/SMA Inhibitory

Serious: 0/11 (0%)

Deaths: 0/11

preSMA/SMA Facilitatory

Serious: 1/11 (9%)

Deaths: 0/11

Sham TMS

Serious: 0/10 (0%)

Deaths: 0/10

Serious adverse events (1 terms)

Reaction	System	DLPFC Facilitatory	preSMA/SMA Inhibitory	preSMA/SMA Facilitatory	Sham TMS
Deterioration of psychiatric disorder	Psychiatric disorders	—	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	DLPFC Facilitatory	preSMA/SMA Inhibitory	preSMA/SMA Facilitatory	Sham TMS
mild nausea	Nervous system disorders	—	—	—	—
neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
altered visual perception	Nervous system disorders	—	—	—	—

Most-reported serious reactions: Deterioration of psychiatric disorder.

Data from ClinicalTrials.gov NCT03275766 adverse events section.

Sponsor's own description

Psychomotor slowing may occur in major psychiatric disorders, such as major depressive disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills, motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15 sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor slowing in schizophrenia or major depression.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.