DDN in Stroke--COBRE

NCT05196737 | Completed Results

• 2 other identifiers: 001165755P20GM109040
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

Dry Needling; Nervous System; Central Nervous System; Reflexes

Outcome Measures

Primary Outcomes (4)

• Changes in the H-reflex Amplitude in Response to Nerve Stimulation

  H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal excitability. This will be measured in the tibialis anterior and the triceps surae.

  7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN

• Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves

  Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.

  7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN

• Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation

  Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.

  7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN

• Ability to Move the Limb as Measured by Range of Motion (ROM)

  ROM is measured in degrees using a standard goniometer. ROM will be measured both passively (moved by the assessor) and actively (participant moves the leg themselves) and the value reported is the maximum degree of dorsiflexion in each condition. Positive values indicate degrees of dorsiflexion beyond neutral, negative values indicate degrees of plantarflexion. Greater values indicate greater degrees of dorsiflexion.

  Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.

Secondary Outcomes (4)

• Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity

  Timepoints are defined as baseline, 0-minutes post, 90 minutes post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.

• Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)

  baseline, immediately after DDN, 90 minutes after DDN, 24 hours after, and 72 hours after DDN

• Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain

  7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN

• Change in Time Needed to Walk 10 Meter (10 m Walk Test)

  Timepoints are defined as baseline, 0-minutes post, 24 hours post and 72 hours post DDN during intervention week and the corresponding 4 timepoints the week prior (non-intervention) but without DDN.

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Behavioral: Dry Needling

Interventions

Dry Needling 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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Neurologic Manifestations

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Gretchen Seif, PT, DPT, MHS, OCS, FAAOMPT
• Organization: Medical University of South Carolina

seif@musc.edu

(843) 792-9345

Study Officials

• Gretchen Seif, DPT

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 19, 2022
• Study Start: March 7, 2022
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)