Tracking a Tactile Signal Along the Nervous System

Stroke Clinical Trial

Official title:

Tracking a Tactile Signal Along the Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06231810
• Other study ID #: 23-1256
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: March 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Netta Gurari, PhD
• Phone: 540-231-3073
• Email: gurari[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Quantify the flow of a tactile signal from the stimulus at the finger at the peripheral nervous system (PNS), to the central nervous system (CNS), and to cognitive perception at the brain in young adults (Aim 1) and individuals with and without stroke (Aim 2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-right-hand dominance for participants who are neurotypical

For Aim 1:

-age range of 18-23

For Aim 2:

• participants who are neurotypical will be a similar age to the participants with stroke

• participants who are neurotypical will have no musculoskeletal and neurological conditions

• participants with stroke will have a single stroke incident resulting in a unilateral lesion (ischemic and hemorrhagic)

• participants with stroke will be in the chronic phase (>1 year from stroke onset)

• participants with stroke will have an onset of stroke after the age of 18

• participants with stroke who meet the criteria of having the capacity to provide informed consent, regardless of aphasia

Exclusion Criteria:

• minors

• pregnant women

• prisoners

• adults not capable of consenting on their own behalf.

For Aim 2:

• participants with stroke who have used antispastic injections in the past six months

• participants with stroke who have a lesion in the brainstem and/or cerebellum

• participants with stroke who have a stroke arising due to brain surgery

• participants with stroke who have hemineglect

Related Conditions & MeSH terms

• Stroke
• Tactile Perception

Intervention

Behavioral:
• Tactile stimulation
Tactile stimuli of differing magnitudes will be applied

Locations

Country	Name	City	State
United States	Virginia Tech	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peripheral nerve function	Electrotactile stimuli will be applied to a finger, with the current (A) changing in magnitude. We will measure the level to which the peripheral nerve is activated using surface electrodes, which identify changes in voltage along the nerve.	30 minutes during the first session of a one session evaluation protocol
Primary	Conscious detection threshold	The magnitude at which a force stimulus applied to the finger can be first consciously detected. Different force levels will be applied, and the participant will indicate which of these forces can be detected. The changes in force applied will be in the units of N.	30 minutes during the first session of a one session protocol
Secondary	Brain activation	The magnitude and regions of brain activated in response to differing levels of force stimuli will be captured using fMRI. The % signal change in the brain will be used to define the brain activation in response to each force stimulus level.	60 minutes during the first session of a one session protocol