HAND-HAND: Stimulate One Hand to Improve Tactile Perception on the Other

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06149325

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post-stroke Sensory Deficits at the Hand	Procedure: Repetitive somatosensory stimulation (RSS) Procedure: Sham Repetitive somatosensory stimulation (RSS)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Basic Science

Official Title:

Stimulate One Hand to Improve Tactile Perception on the Other

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Repetitive somatosensory stimulation (RSS) Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes 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
Experimental: 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.	Procedure: Repetitive somatosensory stimulation (RSS) Tactile stimuli on the index finger of the intact hand, for a duration of 45 minutes 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

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Repetitive somatosensory stimulation (RSS)

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

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

Experimental: Sham Repetitive somatosensory stimulation (RSS), then RSS

Procedure: Repetitive somatosensory stimulation (RSS)

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

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

Outcome Measures

Primary Outcome Measures

Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS [Immediate after the 45 minutes of RSS]
To show that RSS applied for 45 minutes on the index finger of the spared hand in stroke patients suffering from sensory deficits improves their tactile sensitivity on the affected (unstimulated) hand, measured in terms of improved spatial discrimination and/or improved absolute detection.

Secondary Outcome Measures

Jebsen-Taylor hand function test (JTHFT) [Immediate after the 45 minutes of RSS]
Overall functionality of the hand, especially with regard to handling objects
Manual dexterity Pegboard test [Immediate after the 45 minutes of RSS]
Assessment of manual dexterity of the affected unstimulated hand (as well as of the spared hand)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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
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

Exclusion Criteria:

• Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Groupement Hospitalier du Sud - Hôpital Henry Gabrielle	Saint-Genis-Laval		France	69230

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT06149325

Other Study ID Numbers:

69HCL23_0913
2023-A01994-41

First Posted:

Nov 29, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Stroke

Sensory deficits

RSS

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Nov 29, 2023