Stimulate One Hand to Improve Tactile Perception on the Other

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2026-05-30

Brief Summary

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

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Detailed Description

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Conditions

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Post-stroke Sensory Deficits at the Hand

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study is a comparative study, to show that the administration of RSS stimulation leads to a better performance compared to the administration of Sham stimulation (control). The participant's performance after receiving Sham stimulation will be unchanged compared to the baseline performance measured before the stimulation. On the contrary, participant's performance after receiving RSS stimulation will show a considerable improvement compared to the baseline performance, proving the superiority of RSS stimulation over the control. The study has a cross-over design, where each participant receives both stimulations, on different days. The two stimulations will be administered in a randomized order across participants, and in double-blind.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Experimenter 2 will be in charge of the randomization. He will establish a randomization list through Excel and assign to each patient one of the two possible order (Day 1 RSS / Day 2 Sham OR Day 1 Sham / Day 2 RSS). This Excel will be protected through a password and kept in the CRNL server. He will then fill the envelopes with the order assigned by the randomization list and seal them. Each envelope is assigned an inclusion number.

On the inclusion visit (J0), once the consent form is signed, the sealed envelope will be kept in the medical file of the patient. On the first visit (J1). Experimenter 1 will assess the performance of the patient through the tactile and motor tests, while the Exp2 will be in charge of applying the stimulation.

Once Exp1 finished doing the tactile and motor tasks, she will leave the room and Exp2 will enter in the room, open the sealed envelope and apply the stimulation. He will stay in the room with the patient during the stimulation duration.

Study Groups

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Repetitive somatosensory stimulation (RSS), then SHAM

Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days.

Group Type EXPERIMENTAL

Repetitive somatosensory stimulation (RSS)

Intervention Type PROCEDURE

Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes

Sham Repetitive somatosensory stimulation (RSS)

Intervention Type PROCEDURE

Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds

Sham Repetitive somatosensory stimulation (RSS), then RSS

Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days.

Group Type EXPERIMENTAL

Repetitive somatosensory stimulation (RSS)

Intervention Type PROCEDURE

Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes

Sham Repetitive somatosensory stimulation (RSS)

Intervention Type PROCEDURE

Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds

Interventions

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Repetitive somatosensory stimulation (RSS)

Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes

Intervention Type PROCEDURE

Sham Repetitive somatosensory stimulation (RSS)

Tactile stimuli on the index finger of the intact hand, for a duration of 4 minutes spread over 45 minutes in 6 blocks of 40 seconds

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age: 30-80 years old
* Patients with diagnosis of unilateral (both right and left) ischemic or hemorrhagic stroke
* Stroke event dates at least 3 months before the date of inclusion to the study
* Severe-to-mild 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

* 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
* History of neurological or psychiatric illness
* 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
* Persons in psychiatric care
* Congenital or acquired malformation/injury of the test fingers
* Impossibility to maintain hand position necessary for the tests due to severe spasticity