Continuous negative abdominal pressure device to treat pseudotumor cerebri

OBJECTIVE: To study the effects of an externally applied negative abdominal pressure device designed to lower the effects of intra-abdominal pressure (IAP) on headaches and pulsatile tinnitus in severely obese women with pseu dotumor cerebri (PTC). DESIGN: Short-term clinical intervention trial in the Clinical Research Cen ter. Days 1 and 3 were 'control' days; on days 2 and 4-6 patients were in t he device from 8:00 am to noon and from 1:00 to 5:00 pm, and on nights 7-11 they were in the device from 10:00 pm to 8:00 am. The last four patients w ere treated in a device with a counter-traction mechanism. SUBJECTS: Seven centrally obese women with PTC. MEASUREMENTS: Headache and pulsatile tinnitus severity were graded by the p atient using visual analog scale (1-10) and averaged for the time that the device was in use or not in use. IAP was estimated from urinary bladder pre ssure (UBP) before and during device use. The internal jugular vein (IJV) e lliptical cross-sectional area was measured with B-mode ultrasonography; th e timed average velocity was measured by Doppler. RESULTS: There was a decrease in both headache (6.8 +/- 0.8 to 4.2 +/- 0.8, P < 0.05) and pulsatile tinnitus (4.2 <plus/minus> 0.5 to 1.8 +/- 0.5, P < 0.02) within 5 min, and in headache (to 2.2 <plus/minus> 0.8, P < 0.01) an d tinnitus (to 1.7 <plus/minus> 0.5, P < 0.01) within 1 h of device activat ion. UBP decreased (P < 0.001) from 19.1 +/- 3 to 12.5 +/- 2.8 cmH(2)O. Hea dache remained improved throughout time that the device was used. During th e second week, five of seven patients slept in the device without difficult y and four awoke without headache. There was a progressive decrease (P < 0. 01) in headache during the day after sleeping in the device at night as com pared with days 1 and 3 when it was not used (6.5 <plus/minus> 0.5, day 1; 4.1 +/- 0.7, day 3; 3.1 +/- 0.8, day 8; 2.3 +/-0.8, day 10). Headaches retu rned late in the afternoon in two patients; the device was reactivated and headache again improved. Five patients underwent IJV sonography; the IJV ar ea decreased (129 +/- 53 to 100 +/- 44 mm(2), P = 0.06) without a change in IJV flow (1004 +/- 802 to 1000 +/- 589 ml/min) with the device. When activ ated, the device was pulled into the patient, creating discomfort that was alleviated with the counter-traction mechanism in the last four patients. O ne patient developed a 5 cm area of blisters that resolved when the device was worn over a hospital gown. CONCLUSIONS: Decreasing IAP relieved headaches and pulsatile tinnitus in PT C. When patients slept in the device, they awoke without headache or tinnit us, which remained markedly improved throughout most of the following day. This study supports the hypothesis that PTC in obese women is secondary to an increased IAP.