This is BrainsWay’s global website. The website includes information on clinical indications that were not cleared by the FDA and are considered investigational by the U.S. medical device regulations. The FDA cleared BrainsWay D treatment of Major Depression in patients who failed to respond to one or more anti-depressants in the current episode.
A clinical trial using the Deep TMS H System to treat schizophrenic patients, began in August 2006 at the Shalvata Mental Health Center, Hod-Hasharon, Israel.
In a recent ongoing open trial, feasibility safety and efficacy of the H1 coil in the treatment of negative symptoms and cognitive deficits is studied at the Shalvata Mental Health Center.
9 patients (ages 18-65) received deep transcranial magnetic stimulation (Deep TMS) for duration of four weeks. In contrast to the standard superficial rTMS coils (e.g., figure 8 coil, stimulates one-two centimeters of depth) the H1 coil allows deeper stimulation (three- five centimeters of depth) of neuronal pathways involved in the pathophysiology of schizophrenia.
The Deep TMS sessions were administered for five consecutive days a week for a total of four weeks (total of 20 treatment visits). In each treatment session, subjects received 42 trains of two seconds, with stimulation intensity of 120% of motor threshold, frequency of 20 Hz and off periods of 20 seconds over the left prefrontal cortex (total of 1680 stimulations per session). Each treatment session is approximately 15.5 minutes, subjects will be assesed using Scale for the Assessment of Negative Symptoms (SANS), Positive and Negative Symptom Scale (PANSS),Clinical Global Impression Scale (CGI), Calgari Depression Scale (CDS), Social and Occupational Functioning Assessment Scale (SOFAS) , cognitive self assessment (CSA ).
Patients who were diagnosed with schizophrenia by two senior psychiatrists in accordance with the DSM IV criterions and who scored over 21 in the PANSS negative were included in the study. Cognitive testing using CANTAB (Cambridge Neuropsychological Test Automated Battery, De Luca et al., 2003; Robbins et al., 1998) was administered during visits one, 11 and one week (visit 21) after the completion of the treatment. Up to January 2008, 5 subjects completed the study protocol.
The following measurements showed a significant improvement:
1. Scale for the Assessment of Negative Symptoms ( SANS):
From 55±7.19 at Visit 1 to 37.6±7.43 at Visit 20 (end of treatment), and 34.6±6.8088 at visit 21 (1 week follow up).
2. Positive And Negative Syndrome Scale (PANSS):
From 90.4±5.54 at Visit 1 to 70±6.28 at Visit 20 (end of treatment), and 61±3.4 at visit 21 (1 week follow up).
3. Social and Occupational Assessment Scale (.SOFAS):
From 40.6±2.85 at Visit 1 to 49.4±3.07 at Visit 20 (end of treatment), and 51.2±2.47 at visit 21 (1 week follow up)
4. Calgary Depression Scale (CDS)
From 9.8±1.15 at Visit 1 to 4.2±1.15 at Visit 20 (end of treatment), and 3.6±1.2 at visit 21 (1 week follow up)