search
Back to results

DDN in Stroke--COBRE (CDN)

Primary Purpose

Stroke, Spasticity, Muscle, CVA

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Dry Needling, Nervous System, Central Nervous System, Reflexes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-Intervention Week Reflex Measurements

Dry Needling Reflex Measurements

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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
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.
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.
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.
Change in time needed to walk 10 meter (10 m Walk Test)
Decreased time indicates improved ability to walk

Full Information

First Posted
December 9, 2021
Last Updated
July 5, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute of General Medical Sciences (NIGMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT05196737
Brief Title
DDN in Stroke--COBRE
Acronym
CDN
Official Title
Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke--COBRE
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity, Muscle, CVA
Keywords
Dry Needling, Nervous System, Central Nervous System, Reflexes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Intervention Week Reflex Measurements
Arm Type
No Intervention
Arm Description
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.
Arm Title
Dry Needling Reflex Measurements
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dry Needling
Intervention Description
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 Outcome Measure Information:
Title
Changes in the H-reflex amplitude in response to nerve stimulation
Description
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.
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
Title
Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
Description
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
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
Title
Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
Description
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
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
Secondary Outcome Measure Information:
Title
Change in ability to move the leg as measured by the Fugl-Meyer Assessment (FMA)
Description
An increase in the FMA score indicates better movement of the leg
Time Frame
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
Title
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
Description
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
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, and 72 hours after DDN
Title
Change in the ability to move the limb as measured by range of motion (ROM)
Description
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.
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
Title
Change in pain level as measured by the visual analog scale (VAS) for pain
Description
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.
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
Title
Change in time needed to walk 10 meter (10 m Walk Test)
Description
Decreased time indicates improved ability to walk
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Seif, DPT
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

DDN in Stroke--COBRE

We'll reach out to this number within 24 hrs