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临床试验/NCT06891690
NCT06891690招募中不适用

Use of tDCS Stimulation in Neurological and Gynaecological Conditions

Poznan University of Physical Education1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Barthel scale

研究概览

简要总结

The aim of the study is to test the effect of tDCS stimulation on upper and lower limb function in neurological patients and to reduce pain in gynaecological patients. And the impact of tDCS stimulation on patients' quality of life. Standardised questionnaires will be used for pre- and post-stimulation evaluation.

详细描述

Neurological patients:

  1. Main objective: The aim of the study is to see whether the use of tDCS stimulation incorporated into a rehabilitation programme in post-stroke patients and patients with spinal cord and nerve root dysfunction following neurosurgery and non-surgery will improve upper and lower limb function.
  2. Specific aim: To test whether the application of 1, 5 or 10 tDCS stimulations is sufficient to achieve improvements in upper and lower limb function, taking into account the dominant limb.
  3. Description of the study group

The study will include women and men after stroke and spinal cord and nerve root dysfunction admitted for rehabilitation after surgery and not qualified for surgery, as well as healthy subjects. Study participants will be aged between 20-90 years. Post-stroke subjects with spinal cord and nerve root dysfunction will undergo individual rehabilitation using the PNF (Proprioceptive Neuromuscular Facilitation, Polish for proprioceptive neuromuscular facilitation) neurophysiological method performing upper and lower limb patterns. Rehabilitation will last between one and three months. Inclusion criterion: impairments of upper and lower limb function. Exclusion criterion: no written consent to participate in the study. Due to the assessment to be carried out, participants will be divided into groups:

  • women and men after stroke with and without tDCS stimulation 1, 5 or 10 treatments,
  • women and men with spinal cord and nerve root disorders after surgery with and without tDCS stimulation 1, 5 or 10 treatments,
  • women and men with spinal cord and nerve root disorders not qualified for surgery with tDCS stimulation 1.5 or 10 treatments and without,
  • healthy women and men undergoing all procedures including tDCS stimulation 1.5 or 10 without rehabilitation,
  • women and healthy men undergoing all procedures without tDCS stimulation and rehabilitation.
  1. Methods used in the research:

For the purpose of the study to be conducted, the subjects will have an assessment of:

  • body weight, body height, body composition using the Tanita BC-418 MA device before the start of the study, the subject stands barefoot on the electrodes in the shape of the foot, in his/her hand he/she also grasps the electrodes while being only in underwear and a measurement is taken, body composition indicators like BMI (Body Mass Index), muscle mass, fat mass, lean body mass and water content will be assessed, measured before the start of the study
  • biomechanical and viscoelastic properties of the skin using the MyotonPRO: during the measurement the subject will be in a standing position, the limbs of the subject will be exposed, the skin of both upper limbs (arm and forearm) and lower limbs (thigh and shank) will be assessed, on the anterior, posterior, lateral and medial sides, measurement before and after the test,
  • postural stability using the stabilometric platform Coordination, the subject will stand on the platform barefoot only in underwear, upper limbs placed along the torso, measurement will be done with eyes open and closed for a period of 30 seconds, measurement before and after the test,
  • upper limb reaction time using the Witty SEM Microgate, taking into account the dominant and non-dominant upper limb, the test person will stand in front of special sensors (semaphores) which will display letters and numbers in different colours, when ready the test person will have to find the small green letter 'a' 20 times as fast as possible. The total time of the test will be counted, the test person will be advised to be in comfortable sportswear (not restricting the movement of the upper limbs), the dominant and non-dominant limbs will be evaluated separately, measuring before and after the test,
  • assessment of the squeezing force of the right and left limb (hand dynamometer), test subjects will be asked to grasp the dynamometer and squeeze their hand with maximum force within 5 seconds.
  • lower limb reaction time using the Balance Toutor MedTouch platform, the test person will be in comfortable clothing, will be attached by a special harness to the device's extension arm to avoid a possible fall during the test, the test time for one person will last five minutes, the test person will walk on the device's treadmill at a speed of 3 m/s for two minutes, in order to adapt to the walking pace, in front of him/her on a monitor the test subject will see an image of the path in the forest on which he/she is walking in order to divert his/her attention, the device will then elicit a simulated fall reaction in forward, backward and sideways taking into account the test for the dominant and non-dominant lower limb, at the end of the test a record will be obtained for each test subject, recorded by the device in reaction time values, the test will be performed before and after the test,
  • tDCS Sooma DUO stimulation, the subject will be subjected to neuromodulation of the motor cortex, the treatment will be carried out in the sitting position, the subject will wear a cap with electrodes attached to the head, the treatment time will be 20-30 minutes, the maximum direct current will be 2 mA, the number of treatments will be 1, 5 or 10 (5 or 10 treatments daily from Monday to Friday) in the afternoon. Before and after the neuromodulation, tests will be carried out for the dominant and non-dominant hand: tapping on a tablet for 30 seconds, reflex flop test on a tablet (there will be glowing points that the subject must touch, the shorter the time to touch all the points, the better the score) and nine-hole peg test. In the course of neurostimulation, after 10 minutes the test person will perform mirror therapy, i.e. The subject will then perform mirror therapy, i.e. movements of the dominant hand controlled in the mirror image (wrist extension - 1 minute and 30 seconds pause, wrist flexion - 1 minute and 30 seconds pause, finger flexion and extension - 1 minute and 30 seconds pause, fist clenching and opening - 1 minute and 30 seconds pause, finger inversion and adduction - 1 minute and 30 seconds pause, middle finger tapping - 1 minute and 30 seconds pause, all fingers tapping - 1 minute).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Neurological patients
  • •Inclusion Criteria:
  • •impairment of upper and lower limb function.

排除标准

  • •no written consent to participate in the study.
  • •Gynaecological patients
  • •Inclusion Criteria:
  • •women with selected gynaecological conditions (endometriosis, painful menstruation, dyspareunia, polycystic ovary syndrome) with no treatment other than tDCS stimulation.
  • •Exclusion Criteria:
  • •no written consent to participate in the study.

研究组 & 干预措施

tDCS stimulation

Experimental

The study group will have tDCS stimulation.

干预措施: tDSC stimulation (Other)

结局指标

主要结局

Barthel scale

时间窗: through study completion, an average of 1 year

maximum score 100, the higher the score the more independent the person is

Female Sexual Function Index questionnaire

时间窗: through study completion, an average of 1 year

Maximum score 36, the lower the score the lower the sexual satisfaction

body height using Tanita BC-418 MA device

时间窗: through study completion, an average of 1 year

height will be measured in centimeters

biomechanical and viscoelastic properties of the skin using MyotonPRO

时间窗: through study completion, an average of 1 year

The tissue voltage will be measured in Hertz (Hz)

postural stability using the stabilometric platform Koordynacja

时间窗: through study completion, an average of 1 year

the lower the frequency of anterior-posterior and medial-lateral swings, the better the stability

upper limb reaction time using the Witty SEM Microgate device

时间窗: through study completion, an average of 1 year

the shorter the time in seconds measured with a stopwatch, the better the result,

assessment of right and left limb compression strength (hand dynamometer)

时间窗: through study completion, an average of 1 year

test participants will be asked to grasp the dynamometer and clench their hands at maximum force for 5 seconds, the higher the value measured in kilograms, the greater the hand strength

lower limb reaction time using the Balance Toutor MedTouch platform

时间窗: through study completion, an average of 1 year

the shorter the time expressed in seconds, the better the function of the upper limb

tDCS stimulation

时间窗: through study completion, an average of 1 year

the subject will be subjected to neuromodulation of the motor cortex, the treatment will be carried out in sitting position, the subject will have a cap on his head with electrodes attached, the treatment time will be 20-30 minutes, the maximum value of direct current will be 2 mA, the number of treatments will be 1, 3, 5 or 10 ( 5 or 10 treatments performed daily from Monday to Friday) in the afternoon

tapping test, reflex Flop test, Nine-Hole-Peg Test

时间窗: through study completion, an average of 1 year

before and after the neuromodulation, the shorter the time expressed in seconds, the better the hand performance

questionnaire Rolland-Morris

时间窗: through study completion, an average of 1 year

maximum number of points 24, the higher the point value the higher the disability

ASIS scale

时间窗: through study completion, an average of 1 year

maximum score 5, the higher the score the better the function

Oswestry questionnaire

时间窗: through study completion, an average of 1 year

maximum score 50, the higher the score the greater the disability due to lumbosacral pain

Neck Disability Index questionnaire

时间窗: through study completion, an average of 1 year

maximum score 50, the higher the score the greater the disability due to cervical pain

IEF-5 male sex life assessment questionnaire

时间窗: through study completion, an average of 1 year

A score of 21 or less may indicate symptoms of penile erectile dysfunction

Sexual Satisfaction Scale for Women questionnaire

时间窗: through study completion, an average of 1 year

Maximum score 55, the lower the score the lower the sexual satisfaction

Katz scale (ADL - Activities of Daily Living)

时间窗: through study completion, an average of 1 year

maximum score of 6 indicates preserved activities of daily living, lower scores indicate loss of function

Lawton scale - IADL (basic activities of daily living)

时间窗: through study completion, an average of 1 year

The maximum number of points is 27, the lower the score indicates a reduction in everyday functions

WHOQOL-BREF questionnaire

时间窗: through study completion, an average of 1 year

130 points (this is the maximum number of points that can be obtained) if it is satisfactory quality of life, 26 points (this is the minimum number of points that can be obtained) if there is no satisfactory quality of life

Insomnia Severity Index

时间窗: through study completion, an average of 1 year

maximum score of 28 indicating severity of insomnia symptoms, the lower the score the lower the insomnia symptoms

body weight using Tanita BC-418 MA device

时间窗: through study completion, an average of 1 year

body weight will be measured in kilograms

次要结局

未报告次要终点

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Sponsor

研究点 (1)

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