Use of tDCS Stimulation in Neurological and Gynaecological Conditions

Condition(s) studied

Investigational drug(s) / intervention(s)

tDSC stimulation: tDCA stimulation not exceeding 2 mA

Study summary

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.

Eligibility

Primary outcome measure(s)

• body height using Tanita BC-418 MA device — through study completion, an average of 1 year
  height will be measured in centimeters
• biomechanical and viscoelastic properties of the skin using MyotonPRO — through study completion, an average of 1 year
  The tissue voltage will be measured in Hertz (Hz)
• postural stability using the stabilometric platform Koordynacja — 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 — 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) — 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 — 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 — 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 — 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 — through study completion, an average of 1 year
  maximum number of points 24, the higher the point value the higher the disability
• Barthel scale — through study completion, an average of 1 year
  maximum score 100, the higher the score the more independent the person is
• ASIS scale — through study completion, an average of 1 year
  maximum score 5, the higher the score the better the function
• Oswestry questionnaire — 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 — through study completion, an average of 1 year
  maximum score 50, the higher the score the greater the disability due to cervical pain
• Sexual Satisfaction Scale for Women questionnaire — through study completion, an average of 1 year
  Maximum score 55, the lower the score the lower the sexual satisfaction
• Female Sexual Function Index questionnaire — through study completion, an average of 1 year
  Maximum score 36, the lower the score the lower the sexual satisfaction
• IEF-5 male sex life assessment questionnaire — through study completion, an average of 1 year
  A score of 21 or less may indicate symptoms of penile erectile dysfunction
• Katz scale (ADL - Activities of Daily Living) — 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) — 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 — 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 — 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 — through study completion, an average of 1 year
  body weight will be measured in kilograms

Trial sites (1)

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