Status:
UNKNOWN
tDCS in Post-stroke Neglect Rehabilitation
Lead Sponsor:
Universitat Oberta de Catalunya
Collaborating Sponsors:
Hospital Beata María Ana
Universidad Francisco de Vitoria
Conditions:
Stroke
Neglect, Hemispatial
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
Introduction Stroke is the main cause of disability in the world and its sequelae have a great impact in the functional independence and quality of life of patients and families. Unilateral spatial n...
Detailed Description
Transcranial direct current stimulation (tDCS) is a safe and non-invasive neurophysiological technique with enough scientific literature that supports its effectiveness and safety, both in healthy sub...
Eligibility Criteria
Inclusion
- Hemorrhagic or ischemic stroke in the right hemisphere.
- Stroke 3 to 12 months since the event (regardless of whether or not they have received prior rehabilitation).
- 18 to 99 years-old.
- Neuroimaging study.
- Absence of previous strokes.
- Functional capacity that allows him/her to remain seated and active for one hour (Barthel Index score greater than 5 in the item of transfers between chair and bed; this item can be scored from 0 to 15, being 0 totally dependent and 15 totally independent).
- Right-handed manual dominance
- Neglect scores on at least two of the three tests administered for the assessment of visuospatial neglect.
- Signature of informed consent by the patient or his/her legal guardian.
Exclusion
- Dermatological problems (psoriasis, dermatitis on the scalp or face).
- Presence of implants or metal parts in the head excluding fillings.
- Pacemakers, medication pumps, stimulators (vagal, cerebral, transcutaneous), ventriculoperitoneal shunts or aneurysm clips.
- Presence of previous strokes.
- Neurological disease other than stroke described in the inclusion criteria.
- Severe cognitive impairment assessed using the Mini-mental state examination (MMSE), excluding patients with scores under 24 (the score of MMSE are between 0 and 30, being 0 severe cognitive impairment and 30 no cognitive impairment).
- Significant language difficulties that not allow proper understanding of activities or severely limit expression.
- History of alcohol or drug abuse.
- Moderate or severe active depression.
- Uncontrolled medical problems (pathologies in acute phase without medical or pharmacological treatment with proven efficacy or pathologies with imminent life risk).
- Pregnancy or suspected pregnancy that will be checked by pregnancy test at the beginning of the study in patients of childbearing age and with the recommendation of the use of contraceptive methods until the end of the intervention.
Key Trial Info
Start Date :
November 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04458974
Start Date
November 8 2019
End Date
November 1 2023
Last Update
November 9 2022
Active Locations (1)
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1
Hospital Beata María Ana (Brain Damage Unit)
Madrid, Spain, 28007