DDN in Stroke--COBRE

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Spasticity, Muscle, CVA

Intervention / Treatment
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* Behavioral: Dry Needling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-Intervention Week Reflex Measurements<br>Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week. | |
| Experimental: Dry Needling Reflex Measurements<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ability to move the leg as measured by the Fugl-Meyer Assessment (FMA) | An increase in the FMA score indicates better movement of the leg | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, 90 minutes after DDN, 24 hours after, and 72 hours after 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. | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after DDN, 90 minutes after DDN, 24 hours after, and 72 hours after DDN | 
| Change in the ability to move the limb as measured by range of motion (ROM) | ROM is measured in degrees using a standard goniometer. Increased ROM, which will be measured both passively (moved by the assessor) and actively (participant moves the leg themselves), indicates improved ability to move the limb. | 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 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 | 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reflexes, Dry Needling, Nervous System, Central Nervous System