RECRUITMENT

Þátttakendur

Þátttakendur verða einstaklinga sem hafa verið greindir með geðrofssjúkdóm, og sækja þjónustu á Geðsviði Landspítala Háskólasjúkrahúss. Öllum þeim sem sækja þjónustu á Laugarási, sérhæfðri endurhæfingargeðdeild, 5 daga deild, 7 daga deild og göngudeild á Kleppi og uppfylla skilyrði verður boðin þátttaka.

Inntökuskilyrði eru:

1) geðrofssjúklingar á aldrinum 18-55 ára, 2) heyra þrálátar raddir í heyrnarofskynjunum sem svara ekki lyfjameðferð (s.s. búið að prófa að minnsta kosti tvo ráðlagða lyfjaskammta í 6-8 vikur), 3) hafa heyrt raddirnar í að minnsta kosta 1 ár, og 4) heyra raddirnar að minnsta kosti einu sinni á dag.

Útilokunarviðmið eru:

1) flogaveikisaga, 2) dagleg kannabis neysla, 3) notkun annarra sterkra eiturlyfja einum mánuði áður en meðferð hefst, 4) drekkur meira en þrjár alkahól einingar á dag, 5) notar benzodiazepine lyf, 6) notar flogaveikislyf eða 7) nær einhverjum af útilokunarviðmiðun í öryggisskimunarlistanum fyrir utankúpusegulörvun Yfirlæknar á geðdeildum landspítalans verða spurðir hvort þeir viti um sjúklinga á deildum hjá sér sem svara ekki lyfjameðferð og heyra viðvarandi raddir í heyrnarofskynjunum. Með leyfi yfirlæknanna verður rannsóknin kynnt fyrir sjúklingum. Öllum þeim sem uppfylla þátttökuskilyrði verður boðin þátttaka. Þrjátíu þátttakendur sem samþykkja að taka þátt og skrifa undir upplýst samþykki verður skipt handahófskennt upp í tvo hópa.

RECRUITMENT

If you experienced auditory verbal hallucinations and have continuous visits with a psychiatrist from Iceland please check if you are available to be included in this clinical applied study and TMS treatment.

If the randomized clustering result put you in the Control Group (CG) with false TMS treatment you will benefit of a real treatment of 10 days when the study will be concluded.

Inclusion criteria will be:

1) Patients between 18-55 years of age,

2) with treatment resistant AVH due to schizophrenia or schizoaffective disorder.

3) for at least 1 year, and

4) experiences AVH at least once per hour.

Treatment resistance AVH refers to two pharmacotherapy attempts that used recommended dosage for at least 6-8 weeks.

Exclusion criteria will be:

1) History of epilepsy,

2) daily Cannabis use,

3) Use of other hard drugs within one month prior to the study or during the study,

4) Drinks more than three units of alcohol daily,

5) Uses benzodiazepine daily,

6) Uses antiepileptic agents,

7) meet any of the exclusion criteria on the rTMS safety screening list or

8) left handedness, which we will assess with Edinburgh Handedness Inventory.

Patients that meet the inclusion criteria will be offered to take part in the study.

HANDEDNESS EDINBURGH in Icelandic

Please indicate your preferences in the use of hands in the following activities by putting + in the appropriate column. Where the preference is so strong that you would never try to use the other hand unless absolutely forces to, put ++. If any case you are really indifferent put + in both columns. Some of the activities require both hands. In these cases the part of the task, or object, for which hand preference is wanted is indicated in brackets. Please try to answer all the questions, and only leave a blank if you have no experience at all of the object or task.

Left Right

1. Writing

2. Drawing

3. Throwing

4. Scissors

5. Toothbrush

6. Knife (without fork)

7. Spoon

8. Broom (upper hand)

9. Striking Match (match)

10. Opening box (lid)

i. Which foot do you prefer to kick with?

ii. Which eye do you use when using only one?

TMS screening in Icelandic

Screening 13-item Questionnaire for rTMS Candidates

(1) Do you have epilepsy or have you ever had a convulsion or a seizure?

(2) Have you ever had a fainting spell or syncope? If yes, please describe on which occasion(s)?

(3) Have you ever had a head trauma that was diagnosed as a concussion or was associated with loss of consciousness?

(4) Do you have any hearing problems or ringing in your ears?

(5) Do you have cochlear implants?

(6) Are you pregnant or is there any chance that you might be?

(7) Do you have metal in the brain, skull or elsewhere in your body (e.g., splinters, fragments, clips, etc.)? If so, specify the type of metal.

(8) Do you have an implanted neurostimulator (e.g., DBS, epidural/subdural, VNS)?

(9) Do you have a cardiac pacemaker or intracardiac lines?

(10) Do you have a medication infusion device?

(11) Are you taking any medications? (please list)

(12) Did you ever undergo TMS in the past? If so, were there any problems.

(13) Did you ever undergo MRI in the past? If so, were there any problems.

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