Stimulate the Face to Improve Tactile Acuity on the Hand (FACEHAND)

Civil Hospices of Lyon

Status: Unknown

Conditions: Stroke; Face; RSS

Treatments: Procedure: RSS

Study type: Interventional

Funder types: Other

Identifiers

NCT04745247

69HCL20_0888

2020-A03467-32 (Other Identifier)

Details and patient eligibility

About

The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.

Enrollment: 25 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 30-80 years old
• Patients with diagnosis of unilateral (both right and left) ischemic or haemorrhagic stroke
• Stroke event dates at least 3 months before the date of inclusion to the study
• Mild-to-moderate sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand)
• Capacity to provide written consent
• Affiliation to a social security scheme

Non-Inclusion Criteria:

• Sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy
• Severe speech disorder, global aphasia and/or cognitive impairment
• Multiple stroke events
• Bilateral stroke event
• Hemineglect
• History of neurological or psychiatric illness
• Allergy to glue/tape
• Male participants refusing to shave their moustaches or beards during the study
• Other experimental procedure is forbidden during the weeks where the study is performed
• Pregnant, parturient and lactating women
• Persons deprived of their liberty
• Adult persons subject to a legal protection measure: guardianship, curatorship
• Congenital or acquired malformation/injury of the test finger

Exclusion criteria

• Impossibility to maintain hand position necessary for the tests due to severe spasticity
• Severe impairment of the sensibility of the face preventing the administration of the RSS
• Severe impairment of the absolute touch detection at the affected hand preventing measurement (threshold 512 mN)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

RSS

Experimental group

Description:

Repetitive somatosensory stimulation (RSS)

Treatment:

Procedure: RSS

Sham RSS

Placebo Comparator group

Description:

Sham Repetitive somatosensory stimulation (RSS)

Treatment:

Procedure: RSS