Effectiveness of rTMS and Retraining in the Treatment of Focal Hand Dystonia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change From Baseline in Global Rating of Change at Posttest (Day 5)
研究概览
简要总结
This study is exploring a new experimental procedure in dystonia called repetitive transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of the study is to determine whether repetitive TMS is effective as a treatment to reduce symptoms in dystonia as demonstrated by improved motor performance.
详细描述
BACKGROUND: Though the etiology of focal hand dystonia (FHD) is uncertain, two primary factors implicated in the development of dystonic symptoms are excessive cortical excitability and impaired sensorimotor processing.
OBJECTIVE
The purpose of this study was to determine the functional efficacy and neural effects of a Dual intervention of rTMS and sensorimotor retraining. Our working hypothesis is: subjects receiving the combined intervention will (1) display significantly improved handwriting measures; (2) report significant improvement in daily functional ability; (3) display reduced hand cramping compared; and (4) demonstrate reduced corticospinal excitability after the Dual intervention when compared to the rTMS+ stretching and massage (Sham) intervention.
METHODS: A randomized, single-subject, multiple baseline design with crossover is used for this study that will examine ten subjects with FHD with two interventions: five days of low-frequency 1 Hz rTMS + sensorimotor retraining (Dual intervention) vs. rTMS + stretching and massage (Sham). The rTMS is applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses. For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 years of age
- •Symptoms of focal hand dystonia or writer's cramp
排除标准
- •History of seizure or other neurologic disorder
研究组 & 干预措施
rTMS + SMR, then rTMS + CTL
First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining (SMR). Second phase of treatment: rTMS and control treatment (CTL) (CTL therapy consisted of non-specific therapy that includes stretching, massage, range of motion).
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
rTMS + SMR, then rTMS + CTL
First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining (SMR). Second phase of treatment: rTMS and control treatment (CTL) (CTL therapy consisted of non-specific therapy that includes stretching, massage, range of motion).
干预措施: Sensorimotor Retraining (Behavioral)
rTMS + SMR, then rTMS + CTL
First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining (SMR). Second phase of treatment: rTMS and control treatment (CTL) (CTL therapy consisted of non-specific therapy that includes stretching, massage, range of motion).
干预措施: Non-specific Therapy (Behavioral)
rTMS + CTL, then rTMS + SMR
First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion. Second phase of treatment: rTMS and sensorimotor retraining (SMR).
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
rTMS + CTL, then rTMS + SMR
First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion. Second phase of treatment: rTMS and sensorimotor retraining (SMR).
干预措施: Sensorimotor Retraining (Behavioral)
rTMS + CTL, then rTMS + SMR
First phase of treatment: Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion. Second phase of treatment: rTMS and sensorimotor retraining (SMR).
干预措施: Non-specific Therapy (Behavioral)
结局指标
主要结局
Change From Baseline in Global Rating of Change at Posttest (Day 5)
时间窗: Baseline and Posttest
Symptom severity was assessed using the global rating of change (GROC). For the GROC, participants were asked to identify between one to three functions most impacted by focal hand dystonia. At posttest 1 they were then asked to select a rating of perceived change that represented the level of function compared to baseline. Perceived change consisted of a ±7 point Likert scale (+7= a very great deal better, 0= no change, -7= a very great deal worse).
次要结局
- Change From Baseline in Sensation at Posttest (Day 5)(Baseline and Posttest)
- Change From Baseline in Cortical Silent Period at Posttest (Day 5)(Baseline and Posttest)
- Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)(Baseline and Posttest)
- Change From Baseline in Physical Function at Posttest (Day 5)(Baseline and Posttest)
- Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)(Baseline and Posttest)
- Change From Baseline for Physician Rated Impairment at Posttest (Day 5)(Baseline and Posttest)