A treatmentstudy for apathy in schizophrenia.

Randomized controlled trial of neurostimulation treatment for apathy in schizophrenia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20441

Enrollment

125

Registered

2013-01-16

Start date

2012-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

*Apathy - apathie *Cognitive functioning - cognitief functioneren *Schizophrenia - schizofrenie

Interventions

Prior to treatment, the patients will be asked to complete questionnaires, interviews and neuropsychological tests, and an (f) MRI scan will be made. The neurostimulative treatment, rTMS or tDCS, will

Eligibility

Inclusion criteria

Inclusion criteria: 1. At least 18 y.o.a.; 2. Diagnosis schizophrenia, according to DSM IV; 3. Minimum score AES (27).

Exclusion criteria

Exclusion criteria: fMRI: 1. Metal implants (pacemaker, heart valves, vascular clips, eye-implants, copper containing intra-uterine devices, or non-removable piercing); 2. Any risk of having metal particles in the eyes due to manual work without proper eye protections; 3. Tattoos containing iron oxide (often found in red pigments); 4. (Suspected) Pregnancy; 5. Claustrophobia; 6. Refused to be informed (via the general practisioner of the patient) of structural brain abnormalities that could be detected during the experiment. TMS: 1. Diagnosis of epilepsy, or a personal or first degree family history of epileptic seizures; 2. Medications associated with increased seizure risk; 3. Brain surgery; 4. Neurological problems in the past or at present; 5. Intracerebral implants. tDCS: 1. Metal implants inside the skull or eye; 2. Severe scalp skin lesions. Relative contra-indications for tDCS: 1. A history of previous seizures or predisposing factors that might increase seizure risk such as neuromodulatory medication.

Design outcomes

Primary

Measure	Time frame
The main objective is to investigate whether treatment using neurostimulation (tDCS or rTMS) targeting the rDLPFC reduces apathy in schizophrenia patients by activating the targeted brain region and whether tDCS is equally effective as rTMS. Thus, we investigate whether tDCS and / or rTMS increases the activity of the dorsolateral PFC - striatal circuit AS measured by fMRI, and thereby reduces ratings of apathy (and associated impairments of executive functions) as indexed by the Apathy Evaluation Scale, and increases goal-directed behaviour as measured by the Acti-meter.	—

Measure

Time frame

The main objective is to investigate whether treatment using neurostimulation (tDCS or rTMS) targeting the rDLPFC reduces apathy in schizophrenia patients by activating the targeted brain region and whether tDCS is equally effective as rTMS. Thus, we investigate whether tDCS and / or rTMS increases the activity of the dorsolateral PFC - striatal circuit AS measured by fMRI, and thereby reduces ratings of apathy (and associated impairments of executive functions) as indexed by the Apathy Evaluation Scale, and increases goal-directed behaviour as measured by the Acti-meter.

—

Secondary

Measure	Time frame
A secondary aim is to evaluate if a psychosocial intervention, in the form of BAT, in addition to a biological intervention, TMS, further reduces the level of apathy. The to be compared measures are the level of apathy as indexed by the AES, and psychomotor activity obtained by the Acti-meter. In addition, we will investigate which patients are more likely to benefit from rTMS treatment. Applying near-infrared spectroscopy (NIRS) before, and during the first TMS session will enable us to investigate whether baseline frontoparietal connectivity is predictive of the clinical response to rTMS.	—

Measure

Time frame

A secondary aim is to evaluate if a psychosocial intervention, in the form of BAT, in addition to a biological intervention, TMS, further reduces the level of apathy. The to be compared measures are the level of apathy as indexed by the AES, and psychomotor activity obtained by the Acti-meter. In addition, we will investigate which patients are more likely to benefit from rTMS treatment. Applying near-infrared spectroscopy (NIRS) before, and during the first TMS session will enable us to investigate whether baseline frontoparietal connectivity is predictive of the clinical response to rTMS.

—

Contacts

Public ContactC. Kos

Cognitive Neuroscience, NeuroImaging Center Ant.Deusinglaan 2

c.kos@umcg.nl+31 (0)50 3638792

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)