Skip to main content
OpenTrials
Completed

NCT Number: NCT05196737

DDN in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases CVA Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity, Muscle Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dry Needling

Behavioral

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.

Primary outcomes

  1. Changes in the H-reflex Amplitude in Response to Nerve Stimulation

    Time frame: 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.

  2. Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves

    Time frame: 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.

  3. Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation

    Time frame: 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.

  4. Ability to Move the Limb as Measured by Range of Motion (ROM)

    Time frame: 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 outcomes

  1. Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity

    Time frame: 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.

  2. Change in Spasticity as Measured by the Modified Ashworth Scale (mAS)

    Time frame: 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

  3. Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain

    Time frame: 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.

  4. Change in Time Needed to Walk 10 Meter (10 m Walk Test)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Acronym: CDN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2022
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.