Stimulate the Face to Improve Tactile Acuity on the Hand

Stroke Clinical Trial

— FACEHAND  

Official title:

Using a New Form of Cross-border Plasticity Within the Somatosensory Cortex: Stimulate the Face to Improve Tactile Acuity on the Hand

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04745247
• Other study ID #: 69HCL20_0888
• Secondary ID: 2020-A03467-32
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 21, 2023

Study information

• Verified date: February 2021
• Source: Hospices Civils de Lyon
• Contact: Jacques LUAUTE, PU-PH
• Phone: 4 78 86 50 23
• Email: jacques.luaute[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: February 21, 2023
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Face
• RSS
• Stroke

Intervention

Procedure:
• RSS
Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours Sham Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours : the number of stimuli is reduced compared to the effective RSS

Locations

Country	Name	City	State
France	Groupement Hospitalier du Sud - Hôpital Henry Gabrielle	Saint-Genis-Laval

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tactile acuity : 2 point discrimination test	The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS.; Spatial discrimination of the finger, Absolute threshold detection of the finger.	Week 3
Primary	Tactile acuity : Absolute threshold detection test after 3h of RSS	The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS.; Spatial discrimination of the finger, Absolute threshold detection of the finger.	Week 3
Secondary	Jebsen-Taylor hand function test (JTHFT)	Overall functionality of the hand, especially with regard to handling objects	Week 3
Secondary	Questionnaire comfort/ease to use	A self-reported assessment will be administered after the completion of testing procedure: a custom-made questionnaire including the ease of use, perceived sensations during RSS, easy positioning, pain on removal, positive and negative aspects of RSS, willing to continue using after release from the hospital, and willing to recommend to others.	Week 3