Use of TDCS Stimulation in Neurological and Gynaecological Conditions

NCT06891690 | Recruiting DMC

• 1 other identifier: 20/25
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Spinal Cord Diseases; Nerve Root Disorder; Endometriosis; Dyspareunia; Painful Menstruation; Polycystic Ovary

Keywords

tDCS stimulation; quality of life; pain

Outcome Measures

Primary Outcomes (21)

• body height using Tanita BC-418 MA device

  height will be measured in centimeters

  through study completion, an average of 1 year

• biomechanical and viscoelastic properties of the skin using MyotonPRO

  The tissue voltage will be measured in Hertz (Hz)

  through study completion, an average of 1 year

• postural stability using the stabilometric platform Koordynacja

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

  through study completion, an average of 1 year

• upper limb reaction time using the Witty SEM Microgate device

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

  through study completion, an average of 1 year

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

  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

  through study completion, an average of 1 year

• lower limb reaction time using the Balance Toutor MedTouch platform

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

  through study completion, an average of 1 year

• tDCS stimulation

  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

  through study completion, an average of 1 year

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

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

  through study completion, an average of 1 year

• questionnaire Rolland-Morris

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

  through study completion, an average of 1 year

• Barthel scale

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

  through study completion, an average of 1 year

• ASIS scale

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

  through study completion, an average of 1 year

• Oswestry questionnaire

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

  through study completion, an average of 1 year

• Neck Disability Index questionnaire

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

  through study completion, an average of 1 year

• Sexual Satisfaction Scale for Women questionnaire

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

  through study completion, an average of 1 year

• Female Sexual Function Index questionnaire

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

  through study completion, an average of 1 year

• IEF-5 male sex life assessment questionnaire

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

  through study completion, an average of 1 year

• Katz scale (ADL - Activities of Daily Living)

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

  through study completion, an average of 1 year

• Lawton scale - IADL (basic activities of daily living)

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

  through study completion, an average of 1 year

• WHOQOL-BREF questionnaire

  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

  through study completion, an average of 1 year

• Insomnia Severity Index

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

  through study completion, an average of 1 year

• body weight using Tanita BC-418 MA device

  body weight will be measured in kilograms

  through study completion, an average of 1 year

Study Arms (1)

tDCS stimulation

EXPERIMENTAL

The study group will have tDCS stimulation.

Other: tDSC stimulation

Interventions

tDSC stimulation OTHER

tDCA stimulation not exceeding 2 mA

Also known as: tDCS stimulation

tDCS stimulation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• impairment of upper and lower limb function.

You may not qualify if:

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

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan

Poznan, 61-871, Poland

RECRUITING

MeSH Terms

Conditions

Stroke; Spinal Cord Diseases; Radiculopathy; Endometriosis; Dyspareunia; Dysmenorrhea; Polycystic Ovary Syndrome; Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Małgorzata Wójcik, PhD PT

CONTACT

+48(95) 72 79 100; m.wojcik@awf-gorzow.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: March 24, 2025
• Study Start: February 5, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-02

Locations

PL (1)