DDN in Stroke--COBRE

NCT ID: NCT05196737

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2023-06-16

Brief Summary

The study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. In people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). The purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in the muscle and relieve pain.

The total study duration is 7 visits over 2 weeks. There will be 4 visits the first week, and 3 visits the second week. The first visit will take about 1.5 hours, during which study staff will determine the best placement of electrodes and create a cast of the participant's leg to aid them in quickly placing the electrodes on the remainder of the visits. The second and fifth visits will last about 3.5 hours, and all other visits will last about 1.5 hours. Dry needling will take place on the fifth visit only. During each visit the participant will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and leg function.

Conditions

Stroke; Spasticity, Muscle; CVA

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

All participants completed 2 weeks of the study. Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week, with the aim of tracking any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: BEHAVIORAL

Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.

Interventions

Dry Needling

Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥18 years old
• no known neurological injuries.
• neurologically stable for >6 months (and >1 yr post stroke)
• medical clearance to participate
• unilateral ankle and/or wrist spasticity, confirmed by Modified Ashworth Scale (MAS) > 1 and the presence of spastic hyperreflexia

Exclusion Criteria

• motoneuron injury (i.e. the neurons that give rise to the axons innervating the muscles) with inadequate response to stimulation
• a cardiac condition ( history of myocardial infarction, congestive heart failure, pacemaker use, coronary artery disease, atrial fibrillation, congenital heart disease, uncontrolled hypertension)
• a medically unstable condition (including temporary infections and pregnancy)
• age <18 years old
• cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol
• metal allergies
• needle phobias
• lymphedema over a limb (due to risk of infection/cellulitis)
• abnormal bleeding tendencies
• compromised immune system
• vascular disease
• uncontrolled diabetes
• history of epilepsy (as DDN generates strong somatosensory sensation)
• anxiety disorders or in distress
• botox injection in target muscle within 3 months prior to start of study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Gretchen Seif, DPT

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gretchen Seif, DPT

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P20GM109040

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00116575

Identifier Type: -

Identifier Source: org_study_id