DDN in Stroke--COBRE

Not Applicable

Completed

Conditions: Stroke
Spasticity, Muscle
CVA

Interventions: Behavioral: Dry Needling

Registration Number: NCT05196737

Lead Sponsor: Medical University of South Carolina

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 11

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 & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dry Needling Reflex Measurements	Dry Needling	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.

Primary Outcome Measures

Name	Time	Method
Changes in the H-reflex Amplitude in Response to Nerve Stimulation	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	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.
Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves	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 the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation	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 the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Ability to Move the Limb as Measured by Range of Motion (ROM)	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	An increase in the FMA-LE score indicates better movement of the leg. Score ranges from 0 - 34.
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	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
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	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.
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.	Decreased time indicates improved ability to walk