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临床试验/NCT00453505
NCT00453505已完成1 期

Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 976 人开始时间: 2007年1月14日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
976
试验地点
1
主要终点
To identify task-dependent behavioral and physiological substrates for neuromodulation of motor behavior Aim

研究概览

简要总结

Objectives

When a stroke damages the part of the brain that controls movement, people have weakness and difficulty using their hand. There is often some improvement, but many people have permanent disability in using the affected hand. Our previous research has shown that if we stimulate the nerves or the brain, we can temporarily improve how fast people with and without strokes can move their hands. But improvement is very slight and doesn t last long.

In this study, we are trying to see if different combinations of brain, skin and nerve stimulation might cause more improvement in motor function or learning. For this study, we will only include healthy people who have not had a stroke. We will use one or more types of electrical and magnetic stimulation of skin, nerves and the brain, or recording of behavior or brain activity alone without stimulation.

Study Population

Up to 1500 healthy volunteers, age 18 and older.

What will volunteers do in this study

Visits may include the following procedures:

Electromyography (EMG) which measures electrical activity of muscles.

Transcranial Magnetic Stimulation (TMS) where a wire coil is placed on the scalp, and brief electrical current creates a magnetic pulse that temporarily affect brain activity. This may feel like a pulling sensation where the coil is placed, and may result in twitches in the face, arm, or leg.

Transcranial direct current stimulation (tDCS), a technique in which a very weak electrical current is applied to the head in order to stimulate the brain.

Nerve Stimulation, where sticky pads or small metal disk electrodes attached to wires onto the skin to record muscle and nerve activity.

Magnetic resonance imaging (MRI) which uses a strong magnetic field and radio waves to take pictures of the brain. Some MRIs the volunteers are asked to lie still, and in others are asked to do various movements.

Magnetic resonance spectroscopy (MRS) uses a strong magnetic field and radio waves to take pictures of various chemicals in the brain using an MRI scanner.

Electroencephalogram (EEG) to record the electrical activity of the brain ( brain waves ).

Magnetoencephalography (MEG) records small magnetic field changes from brain activity.

Eye movement recordings

Behavioral Tests

Questionnaires

Pregnancy test (for those capable of getting pregnant)

How long is the study?

Volunteers in this study may have multiple visits. Each visit may last up to 8 hours. The number of visits we depend on the data the researchers want to collect. You may be asked to come back for visits over multiple years (up to 20 years). Taking part in this study is completely voluntary. People who volunteer to be in the study can change their mind at anytime.

详细描述

Objectives

Noninvasive stimulation of the central and peripheral nervous system, including transcranial magnetic stimulation (TMS), transcranial direct and alternating current stimulation (tDCS and tACS, respectively) and cutaneous/peripheral nerve stimulation (C/PNS) alone or paired with TMS (paired associative stimulation, PAS), has been increasingly used in the investigation of cortical plasticity and as a possible adjuvant strategy in neurorehabilitation. It has been shown that TMS, tDCS, tACS and C/PNS can modulate motor function in healthy volunteers, as well as in patients with neurological disorders such as stroke.

One fundamental problem is that the optimal parameters of stimulation to modulate motor function by all of these techniques are not known. The purpose of this protocol has been to explore within safe guidelines, the effects of different stimulation parameters on motor cortical function, on oscillatory brain dynamics measured with magnetoencephalography (MEG) and electroencephalography (EEG), on eye movements, and on fMRI activation. In addition, this protocol was used to train new fellows coming to NINDS Human Cortical Physiology Section (HCPS) in the use of TMS, tDCS, tACS and C/PNS techniques.

We expected that information emerging from these studies would allow us to 1) optimize experimental protocols or stimulation parameters to collect pilot data in healthy volunteers for future patient-oriented hypothesis-driven protocols, 2) to collect pilot data for power analysis for future patient-oriented hypothesis driven protocols, and 3) to train new fellows in the use of these different methods.

As instructed, we had stopped recruitment under this protocol at the time we were informed by the NIH IRB that they determined this to be a thematic protocol (August 6, 2019). The four specific aims addressed under this protocol are:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • Age 18 and older
  • Willingness and ability to give consent
  • Normal neurological examination
  • Clearly dominant handedness (right or left) as assessed by Handedness scales

排除标准

  • Any severe or progressive neurological disorder or severe medical condition, or history of seizures
  • Chronic use of medications acting primarily on the central nervous system, which lower the seizure threshold or significantly alter cortical excitability such as antipsychotic drugs (chlorpromazine, clozapine), tricyclic or other antidepressants, or prescription stimulants.
  • Pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments
  • Diagnosis of drug dependence made by a health care provider (ICD-9-CM code 304)
  • Staff from our section

研究组 & 干预措施

1

Experimental

Healthy Volunteers

干预措施: TMS (Device)

1a

Sham Comparator

Healthy Volunteers

干预措施: TMS (Device)

3a

Sham Comparator

Healthy Volunteers

干预措施: tACS (Device)

2

Experimental

Healthy Volunteers

干预措施: tDCS (Device)

2a

Sham Comparator

Healthy Volunteers

干预措施: tDCS (Device)

4

Experimental

Healthy Volunteers

干预措施: CPNS (Device)

3

Experimental

Healthy Volunteers

干预措施: tACS (Device)

4a

Sham Comparator

Healthy Volunteers

干预措施: CPNS (Device)

结局指标

主要结局

To identify task-dependent behavioral and physiological substrates for neuromodulation of motor behavior Aim

时间窗: in data analysis

in data analysis

To understand variability, rigor or/and reproducibility of brain stimulation effects.

时间窗: in data analysis

in data analysis

To identify resting behavioral and physiological substrates for neuromodulation of motor behavior Aim

时间窗: in data analysis

in data analysis

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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