A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus

이정희
9월 29일
3분 분량

Mark G. Luciano, M.D., Ph.D. et al.

2025년 9월 16일

N Engl J Med

DOI: 10.1056/NEJMoa2503109

Abstract

Background

Idiopathic normal-pressure hydrocephalus is a neurologic disorder characterized by impaired gait, balance, cognition, and bladder control in older adults. The disorder is treated with shunt surgery, but the effectiveness of shunting is unclear.

Methods

We conducted a double-blind, randomized, placebo-controlled trial involving participants selected for shunt surgery on the basis of gait-velocity improvement with cerebrospinal fluid (CSF) drainage. Participants were randomly assigned to an open-shunt valve setting (opening pressure, 110 mm of water) or a placebo valve setting (opening pressure, >400 mm of water) of a noninvasively adjustable shunt. The primary outcome was the change in gait velocity 3 months after surgery. Secondary outcomes were the change at 3 months in the Tinetti scale total score (range, 0 to 28; lower scores indicate worse gait and balance), Montreal Cognitive Assessment (MoCA) score (range, 0 to 30; lower scores indicate worse cognition), and Overactive Bladder Questionnaire score (range, 0 to 100; higher scores indicate worse urinary incontinence).

Results

A total of 99 participants underwent randomization and received the assigned intervention. At 3 months, gait velocity had increased in the open-shunt group (mean [±SD] change, 0.23±0.23 m per second; assessed in 49 participants) and was unchanged in the placebo group (mean change, 0.03±0.23 m per second; assessed in 49 participants), resulting in a treatment difference of 0.21 m per second (95% confidence interval, 0.12 to 0.31; P<0.001). A significantly greater improvement in the open-shunt group than the placebo group was seen for the Tinetti scale score (mean change, 2.9 points vs. 0.5 points; P=0.003) but not the MoCA score (1.3 points vs. 0.3 points) or the Overactive Bladder Questionnaire score (−3.3 points vs. −1.5 points). The results regarding adverse events were mixed, with more participants in the placebo group reporting falls (46% vs. 24%), an equal percentage having cerebral bleeding (2% in both groups), and more participants in the open-shunt group having subdural bleeding (12% vs. 2%) and positional headaches (59% vs. 28%).

Conclusions

Among participants with idiopathic normal-pressure hydrocephalus who had a response to temporary CSF drainage, shunting resulted in significant improvements at 3 months in gait velocity and a measure of gait and balance but not in measures of cognition or incontinence. (Funded by the National Institute of Neurological Disorders and Stroke and the Trial Innovation Network; PENS ClinicalTrials.gov number, NCT05081128.)

Figure 1. Change in Gait Velocity from Baseline to 3 Months. — **Figure 1.** **Change in Gait Velocity from Baseline to 3 Months.**

Table 3. Trial Outcomes. — **Table 3.** **Trial Outcomes.**

요약

· 배경 : 특발성 정상압 수두증(idiopathic normal-pressure hydrocephalus, iNPH)은 노인에서 보행, 균형, 인지기능, 방광 조절의 장애를 특징으로 하는 신경학적 질환이다. 이 질환은 션트 수술(shunt surgery)로 치료하지만, 션트의 효과에 대해서는 명확히 밝혀지지 않았다.

· 방법 :

이 연구는 이중맹검 무작위 위약 대조 임상시험으로 진행되었다.

참가자는 뇌척수액(CSF) 배액 후 보행속도 개선이 확인되어 션트 수술 대상자로 선정되었다.

무작위 배정:
- 오픈 션트(open-shunt) 그룹: 션트 개방 압력 110 mmH₂O
- 위약 션트(placebo-shunt) 그룹: 션트 개방 압력 >400 mmH₂O (사실상 폐쇄 상태)
사용된 션트는 비침습적으로 조정 가능한 션트 밸브였다.

1차 평가 지표(primary outcome):

수술 후 3개월 시점에서의 보행 속도(gait velocity)의 변화

2차 평가 지표(secondary outcomes):

수술 후 3개월 시점의
- Tinetti 점수 (0~28점, 낮을수록 보행·균형 저하)
- MoCA 점수 (0~30점, 낮을수록 인지기능 저하)
- 과활동성 방광 설문지(Overactive Bladder Questionnaire, 0~100점, 높을수록 요실금 심함)

· 결과 :

총 99명이 무작위 배정되어 각각의 치료를 받았다.

3개월 후 결과는 다음과 같았다.

보행 속도(gait velocity)
- 오픈 션트군: 평균 증가 0.23±0.23 m/s
- 위약군: 평균 변화 0.03±0.23 m/s
- 두 군 간 차이: 0.21 m/s (95% CI, 0.12–0.31; P<0.001)
Tinetti 점수 개선
- 오픈 션트군: +2.9점, 위약군: +0.5점 (P=0.003)
MoCA 점수
- 오픈 션트군: +1.3점, 위약군: +0.3점 (통계적으로 유의하지 않음)
과활동성 방광 점수
- 오픈 션트군: –3.3점, 위약군: –1.5점 (유의하지 않음)