CDN: DDN in Stroke--COBRE

Sponsor
Medical University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT05196737
Collaborator
(none)
20
1
2
21.8
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dry Needling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke--COBRE
Actual Study Start Date :
Mar 7, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Non-Intervention Week Reflex Measurements

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

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. Change in ability to move the leg as measured by the Fugl-Meyer Assessment (FMA) [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]

    An increase in the FMA score indicates better movement of the leg

  2. Change in spasticity as measured by the Modified Ashworth Scale (mAS) [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]

    The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.

  3. Change in the ability to move the limb as measured by range of motion (ROM) [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]

    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.

  4. 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.

  5. Change in time needed to walk 10 meter (10 m Walk Test) [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]

    Decreased time indicates improved ability to walk

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina

Investigators

  • Principal Investigator: Gretchen Seif, DPT, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gretchen Seif, DPT, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05196737
Other Study ID Numbers:
  • 00116575
First Posted:
Jan 19, 2022
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gretchen Seif, DPT, Associate Professor, Medical University of South Carolina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 13, 2022