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Procedure

Dry Needling for Stroke (CDN Trial)

N/A

Waitlist Available

Led By Gretchen Seif, DPT

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

CDN Trial Summary

This trial is examining the effects of dry needling on spasticity in people with chronic stroke.

Eligible Conditions

Stroke
Spasticity

CDN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves

Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation

H-Reflex

Secondary outcome measures

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

Pain

Change in spasticity as measured by the Modified Ashworth Scale (mAS)

+2 more

CDN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dry Needling Reflex MeasurementsExperimental Treatment1 Intervention

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.

Group II: Non-Intervention Week Reflex MeasurementsActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dry Needling

2020

Completed Phase 2

~1090

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,248 Total Patients Enrolled

67 Trials studying Stroke

60,039 Patients Enrolled for Stroke

National Institute of General Medical Sciences (NIGMS)NIH

268 Previous Clinical Trials

248,748 Total Patients Enrolled

9 Trials studying Stroke

242 Patients Enrolled for Stroke

Gretchen Seif, DPTPrincipal InvestigatorMedical University of South Carolina

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up to partake in this experiment?

"Indeed, the details on clinicaltrials.gov confirm that this trial is actively seeking participants. It was initially posted on March 7th 2022 and has most recently been updated November 28th of 2022. The study requires 20 volunteers across a single medical centre."

Answered by AI

Are participants currently being sought for this trial?

"According to the information present on clinicaltrials.gov, this research endeavour is still open for recruitment of participants. It was initially advertised in March 2022 and has recently been updated at the end of November."

Answered by AI

What is the aim of this medical experiment?

"This medical trial measures cutaneous reflexes elicited by non-noxious stimulation of nerves, pain levels as measured on a 0 to 10 Visual Analogue Scale (VAS), walking time for the Ten Meter Walk Test, and spasticity using Modified Ashworth Scale (mAS) over 7 days prior. Secondary goals include decreasing VAS scores in order to reduce pain, mitigating issues with locomotion via reduced walk times and abating spasticity through decreased mAs ratings."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DDN in Stroke--COBRE

Gretchen Seif, DPT 2022. "DDN in Stroke--COBRE". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05196737.