NCT00907829

Brief Summary

The purpose of this study is to determine whether neural block and neuromuscular electrical stimulation are effective in treating finger impairment due to stroke.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2009

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 25, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 5, 2014

Status Verified

May 1, 2014

Enrollment Period

3.9 years

First QC Date

May 21, 2009

Last Update Submit

May 1, 2014

Conditions

StrokeCerebrovascular Accident

Keywords

strokefingertip forcemuscle coordination

Outcome Measures

Primary Outcomes (1)

  • fingertip force

    force measured before and after intervention (1 week later)

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

persons with severe hand impairment following hemiparetic stroke

Drug: lidocaineDevice: muscle stimulator

Arm 2

ACTIVE COMPARATOR

persons with severe hand impairment following hemiparetic stroke

Device: muscle stimulator

Interventions

lidocaineDRUG

comparison of the effect of the drug to help improve finger function

Arm 1
muscle stimulatorDEVICE

comparison of the effect of stimulated muscle(s) on finger function

Arm 1Arm 2

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of stroke;
  • stroke occurred no less than 6 months prior to study;
  • must have had only 1 stroke;
  • must demonstrate severe hand impairment;
  • must have no substantial evidence of motor and sensory deficits in non-paretic limb;
  • must have no history or clinical signs of neurologic diseases other than stroke;
  • must have no cognitive dysfunction that precludes comprehension of experimental tasks;
  • must be able to give informed consent

You may not qualify if:

  • taking medication that can increase the risk of lidocaine toxicity such as cimetidine (ulcer treatment drug), phenytoin (anticonvulsant drug), nadolol (drug for treatment of headache, hypertension, chest pain);
  • taking anticoagulant medication, i.e., aspirin, coumadin;
  • has a low platelet count or a bleeding disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Joseph Towles

    Edward Hines Jr. VA Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 25, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 5, 2014

Record last verified: 2014-05

Locations

US(1)