Randomized controlled trial of neurostimulation treatment for apathy in schizophrenia

Randomized controlled trial of neurostimulation treatment for apathy in schizophrenia - Neurostimulation as a treatment of apathy with vulnerability for psychosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41353

Enrollment

150

Registered

2013-09-04

Start date

2013-10-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

apathy listlessness psychosis

Interventions

Three of the five patient groups (25 patients per group) will receive either tDCS, rTMS, or rTMS + BAT treatment. The remaining two patient groups are included as placebo control groups, and will re

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)