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A treatmentstudy for apathy in schizophrenia.


- candidate number14226
- NTR NumberNTR3805
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jan-2013
- Secondary IDs43310 ABR
- Public TitleA treatmentstudy for apathy in schizophrenia.
- Scientific TitleRandomized controlled trial of neurostimulation treatment for apathy in schizophrenia.
- ACRONYMTRENSS2
- hypothesis1. Repetitive Transcranial Magnetic Stimulation (rTMS), Transcranial Direct-Current Stimulation (tDCS) and Behavioural Activation Therapy (BAT) following rTMS will reduce feelings of apathy, increase goal directed behaviour and might be beneficial for cognitive functioning;
2. Neurostimulative treatment and BAT will increase fronto-striatal circuits;
3. Baseline frontoparietal connectivity is predictive of the clinical response to rTMS.
- Healt Condition(s) or Problem(s) studiedCognitive functioning, Schizophrenia, Apathy
- Inclusion criteria1. At least 18 y.o.a.;
2. Diagnosis schizophrenia, according to DSM IV;
3. Minimum score AES (27).
- Exclusion criteriafMRI:
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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-sep-2016
- Target number of participants125
- InterventionsPrior 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 be provided to the patients twice a day, for a duration of 20 minutes. This treatment lasts for 3 weeks, 6 days a week. There are two groups of patients that receive placebo rTMS or placebo tDCS treatment (25 persons per group). During the (placebo) treatment all patients wear an Acti-meter (on the wrist like a watch). A portion of the patients (25 persons), get a 6 week behavioral activation therapy (BAT) after finishing the neurostimulatieve treatment. After completion of the treatment the questionnaires, interviews, neuropsychological tests, and scan will be repeated. During two follow-up sessions, four weeks and three months after the treatment, solely the neuropsychological evaluation and one-week Acti-meter assessment will be repeated.
- Primary outcomeThe 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 outcomeA 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.
- TimepointsDirectly before intervention, during intervention, immediately after intervention, a follow-up 4 weeks after treatment, and a follow-up three months after treatment.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES C. Kos
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A. Aleman
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
NWO VICI grant, Ministry of Education, Culture and Science
- PublicationsN/A
- Brief summaryThis study is a randomized controlled trial whereby effects of neurostimulative treatment and activation therapy for apathy in schizophrenia are investigated. The main objective is to investigate whether treatment using neurostimulation (tDCS or rTMS) targeting the right dorsolateral prefrontal cortex (rDLPFC) reduces apathy in schizophrenia patients by activating the targeted brain region and whether tDCS is equally effective as rTMS. 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. In addition, we will investigate which patients are more likely to benefit from rTMS treatment by applying near-infrared spectroscopy (NIRS).
- Main changes (audit trail)
- RECORD16-jan-2013 - 4-sep-2013


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