1. 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…
ID
Bron
Verkorte titel
Aandoening
*Apathy - apathie
*Cognitive functioning - cognitief functioneren
*Schizophrenia - schizofrenie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
This 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).
Doel van het onderzoek
1. 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.
Onderzoeksopzet
Directly before intervention, during intervention, immediately after intervention, a follow-up 4 weeks after treatment, and a follow-up three months after treatment.
Onderzoeksproduct en/of interventie
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 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.
Algemeen / deelnemers
Ant.Deusinglaan 2
C. Kos
Groningen 9713 AW
The Netherlands
+31 (0)50 3638792
c.kos@umcg.nl
Wetenschappers
Ant.Deusinglaan 2
C. Kos
Groningen 9713 AW
The Netherlands
+31 (0)50 3638792
c.kos@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. At least 18 y.o.a.;
2. Diagnosis schizophrenia, according to DSM IV;
3. Minimum score AES (27).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL3659 |
NTR-old | NTR3805 |
Ander register | ABR : 43310 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |