DDN in Stroke--COBRE

Stroke Clinical Trial

— CDN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05196737
• Other study ID #: 00116575
• Secondary ID: 5P20GM109040
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CVA
• Muscle Spasticity
• Spasticity, Muscle
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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