Randomized controlled trial of neurostimulation treatment for apathy in schizophrenia

Completed

• Conditions: apathy; listlessness; psychosis; 10039628

• Registration Number: NL-OMON41353
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Patients:
- At least 18 y.o.a.
- Diagnosis schizophrenia, according to DSM IV
- Minimum score AES (27)
- Written informed consent
Healthy subjects:
- At least 18 y.o.a.
- written informed consent

Exclusion Criteria

fMRI:
-Metal implants (pacemaker, heart valves, vascular clips, eye-implants, copper containing intra-uterine devices, or non-removable piercing)
- Any risk of having metal particles in the eyes due to manual work without proper eye protections - Tattoos containing iron oxide (often found in red pigments)
- (suspected) Pregnancy
- Claustrophobia
- Refused to be informed (via the general practisioner of the patient) of structural brain abnormalities that could be detected during the experiment;TMS:
- Diagnosis of epilepsy, or a personal or first degree family history of epileptic seizures
- Medications associated with increased seizure risk
- Brain surgery
- Neurological problems in the past or at present
- Intracerebral implants;tDCS:
- Metal implants inside the skull or eye
- Severe scalp skin lesions;Treatment of tDCS of rTMS within the past year.;Relative contra-indications for tDCS:
- A history of previous seizures or predisposing factors that might increase seizure risk such as neuromodulatory medication
Additional exclusion criteria for healthy subjects:
History of psychiatric or neurological illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter concerns the changes in the level of apathy as indexed<br /><br>by the Apathy Evaluation Scale (AES) before and after neurostimulative<br /><br>treatment, and the amount of spontaneous motor behaviour as measured by the<br /><br>Acti-meter. Another important parameter concerns the changes after treatment in<br /><br>the blood oxygenation level dependent (BOLD) response. This concerns the BOLD<br /><br>response at the level of individual brain areas, as well as their functional<br /><br>dynamic interactions. Furthermore, changes in frontoparietal connectivity after<br /><br>tDCS or rTMS treatment are used as a measure of neuroplasticity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>