DDN in Stroke--COBRE (CDN)

Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke--COBRE

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Spasticity, Muscle; CVA
• Intervention / Treatment: Behavioral: Dry Needling

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity	An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34.	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)	The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity. A score of 1.5 reported below is equal to 1+ on the 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	Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased 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)	Decreased time indicates improved ability to walk	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.

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Gretchen Seif, DPT, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): June 16, 2023

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Dry Needling; Central Nervous System; Nervous System; Reflexes
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Muscle Spasticity; Stroke
• Other Study ID Numbers: 00116575; 5P20GM109040 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No