Clinical trial NCT04535479: Dry Needling for Spasticity in Stroke
Official title: Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Muscle Spasticity
Keywords: Dry Needling
Nervous System
Central Nervous System
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study team is recruiting 20 adults with spasticity due to chronic stroke and 20 adults with no neurological injuries for a 2 day study. 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 your skin to produce a muscle twitch response. It is intended to release a knot in your muscle and relieve pain.

The total study duration is 2 days. The first visit will take about 3 hours, during which dry needling will take place, and the second visit will take about 1 hour. During both visits you will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and arm/leg function.


Eligibility criteria: Inclusion Criteria:

For adults with no known neurological conditions:

* ≥18 years old
* no known neurological injuries.

For individuals after stroke:

* 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.

Primary outcomes:
measure: Changes in the H-reflex amplitude in response to nerve stimulation
timeFrame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
measure: 2. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
timeFrame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
measure: 3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
timeFrame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Secondary outcomes:
measure: Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA)
timeFrame: baseline, 90 minutes after DDN, and 72 hours after DDN
measure: Change in spasticity as measured by the Modified Ashworth Scale (mAS)
timeFrame: baseline, 90 minutes after DDN, and 72 hours after DDN
measure: Change in the ability to move the limb as measured by range of motion (ROM)
timeFrame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
measure: Change in pain level as measured by the visual analog scale (VAS) for pain
timeFrame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
measure: Changes in brain activity as measured by electroencephalography (EEG)
timeFrame: baseline, during DDN, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aiko K Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: