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Task-induced sensitized brain circuits during rTMS in major depressive disorder

Task-induced sensitized brain circuits during rTMS in major depressive disorder - rTMS-SENSE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51494
Enrollment
10
Registered
2022-07-22
Start date
2023-06-08
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

High frequency rTMS (10Hz, 4 seconds stimulation, inter train interval of 11 seconds, 75 trains) on the left dorso lateral Prefrontal Cortex (dlPFC), for 20 sessions.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age 18 to 65 years old; Diagnosed with Major Depressive Disorder, current episode depressive Indication for rTMS, as indicated by a psychiatrist Therapy resistance defined by non-response after at least one type of antidepressant and one adequate psychotherapy

Exclusion criteria

Exclusion criteria: Diagnosis of bipolar disorder Current depressive episode with psychotic traits Acute suicidality (History of) neurological disease; (History of) epilepsy; Pregnancy Abnormal hearing or (uncorrected) vision; Current disorder in substance abuse (opiate, ketamine, LSD, (meth)amphetamine, cocaine, solvents, cannabis, benzodiazepines or barbiturate) or alcohol abuse; Any known other serious somatic health problem; Used alcohol within the last 24 hours prior to each test session; Used recreational drugs over a period of 72 hours prior to each test session. rTMS contraindications: ICD, pacemaker, epilepsy in a first degree relative and intracranial metal implants, such as a cochlear implant or deep brain stimulator.. MRI contraindications: metal implants, claustrophobia.

Design outcomes

Primary

MeasureTime frame
Depression outcome is measured using a Hamilton Depression Rating Scale - 17 items and the Inventory of Depressive Symptoms - self rated every 5 sessions.

Secondary

MeasureTime frame
1. Changes in heart frequency using electrocardiogram (ECG) before and during stimulation 2. Changes in E/I ratio using electroencephalogram (EEG) before, during and (directly) after stimulation. 3. Changes in functional brain connectivity using functional MRI.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)