跳至主要内容
临床试验/NCT04618614
NCT04618614Unknown不适用

The Effect of High-definition Transcranial Direct Current Stimulation of the Somatosensory Area on Upper Limb Motor Performance in Healthy Adults

Ariel University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Change in movement time (s) from baseline to intervention

研究概览

简要总结

to investigate the effect of transcranial direct current stimulation of the somatosensory area on upper limb motor performance in healthy adults

详细描述

60 healthy subjects will be randomly allocated to one of three groups: (a) 15- min of High-Definition transcranial direct current stimulation (HD-tDCS) on primary somatosensory cortex (S1) with an intensity of 1 milliampere (mA) (HD-tDCS S1); (b) 15-min of HD-tDCS on primary motor cortex (M1) with an intensity of 1 mA (HD-tDCS M1); and (c) 15-min of sham HD-tDCS (HD-tDCS sham).

The stimulation will be administered noninvasively using an M x N 9-channel high definition transcranial electrical current stimulator from Soterix Medical (New York, NY). In the HD-tDCS S1 group, the anodal stimulation will target the right postcentral gyrus. In the HD-tDCS M1 group, the anodal stimulation will target the right primary motor cortex (brodmann area 4). The location of the electrodes will be placed based on HD-Targets brain modelling software (Soterix Medical, New York, NY).

Tests (motor and sensory tasks): The non-dominant left arm will be tested. Motor task: The subjects will perform a sequential point-to-point movement task on the graphics tablet. Initially, the participants will be required to perform 3 sequences without errors to familiarize themselves with the setup, the task and the sequence. Then, they will perform the pre-test which consists of two blocks of 6 sequences, i.e. 12 sequences, with a 30 s break between blocks. Two min after starting the appropriate stimulation, they will perform 2 blocks of 6 sequences (identical to the pre-test). After finishing the tDCS stimulation, the participants will perform a post-test, which is also identical to the pre-test. Three outcome measures will be used: movement time (s), reaction time (s) and straight line deviation (cm) of the reaching movements. Sensory tasks: discriminative task (two point orientation discrimination) and proprioception task will be included. The sensory tasks will be performed with eyes blindfolded. In the discriminative task the experimenter will deliver a stimuli by a two-pronged instrument at intervals of 2,3,4,5 mm to the distal phalanx of fingers 2 and 5 of the left hand. The stimulus will be oriented either across or down (total of 16 stimuli). Subjects will be asked to Identify the orientation of the stimulation. The outcome measure will be the percentage of correct answers. In the proprioceptive task, the subjects will perform a one direction point-to-point (target) movement task on the graphics tablet. The task will include 20 movements, 10 passive movements and 10 active movements. After every passive movement with eyes blindfolded, the subject will be asked to perform a similar active movement. Initially, the participants will be asked to perform four movements to familiarize themselves with the setup (the first two movements will be passive and active movements with eyes open, and the following two movements will be passive and active movements with eyes blindfolded). The outcome measure will be the end point error (cm) which is the distance between the target and the actual arrival location.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •aged between 20 and 35
  • •right-hand dominant
  • •healthy according to self report

排除标准

  • •taking psychiatric medications
  • •a history of drug / alcohol abuse or dependence
  • •psychiatric or neurological disorder
  • •a history of seizures
  • •metal implants in their head
  • •musculoskeletal deficits interfering with task performance (proper reaching performance in sitting)

研究组 & 干预措施

HD-tDCS S1 1 mA

Experimental

Single session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour.

干预措施: HD-tDCS 1 mA to S1 (Device)

HD-tDCS M1 1 mA

Active Comparator

Single session of 15-min HD-tDCS to the right primary motor cortex with an intensity of 1 mA. The session will last approximately one hour.

干预措施: HD-tDCS 1 mA to M1 (Device)

Sham control

Sham Comparator

Single session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour.

干预措施: Sham control (Device)

结局指标

主要结局

Change in movement time (s) from baseline to intervention

时间窗: Baseline (immediately before stimulation), two minutes after starting the stimulation

Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.

Change in movement time (s) from baseline to posttest

时间窗: Baseline (immediately before stimulation), immediately post stimulation

Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.

Change in movement time (s) from intervention to posttest

时间窗: Two minutes after starting the stimulation, immediately post stimulation

Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.

Change in reaction time (s) from baseline to intervention

时间窗: Baseline (immediately before stimulation), two minutes after starting the stimulation

Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.

Change in reaction time (s) from baseline to posttest

时间窗: Baseline (immediately before stimulation), immediately post stimulation

Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.

Change in reaction time (s) from intervention to posttest

时间窗: Two minutes after starting the stimulation, immediately post stimulation

Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.

Change in straight line deviation (cm) from baseline to intervention

时间窗: Baseline (immediately before stimulation), two minutes after starting the stimulation

Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.

Change in straight line deviation (cm) from baseline to posttest

时间窗: Baseline (immediately before stimulation), immediately post stimulation

Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.

Change in straight line deviation (cm) from intervention to posttest

时间窗: Two minutes after starting the stimulation, immediately post stimulation

Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.

次要结局

  • Change in the correct answers (%) of discriminative task from baseline to posttest(Baseline (immediately before stimulation), immediately after the motor posttest)
  • Change in end point error (cm) of proprioception task from baseline to posttest(Baseline (immediately before stimulation), immediately after the motor posttest)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验