Brain Plasticity in Carpal Tunnel Syndrome and Its Respon... | NCT01345994

Studies
Brain Plasticity in Carpal Tunnel Syndrome and Its Response to Acupuncture

NCT01345994

Sponsor

Martinos Center for Biomedical Imaging

Status

Unknown status

Last Update Posted

May 2, 2011Estimated

Enrollment

Not provided

Phase

Early Phase 1

Conditions

Carpal Tunnel Syndrome

Interventions

electro-acupuncture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AT004714-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Apr 25, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2011

Last Update Posted Date

May 2, 2011Estimated

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture - local	Experimental	acupuncture on forearm only	Procedure: electro-acupuncture
acupuncture - distal	Experimental	acupuncture on both arm and leg	Procedure: electro-acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electro-acupuncture	Procedure	acupuncture stimulation with electricity	Acupuncture - local acupuncture - distal

Measure	Description	Time Frame
Functional MRI brain response	Several fMRI outcomes will be assessed including brain hyperactivity and somatotopy	Baseline vs. Post-Acupuncture (average 9 weeks later)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female adults aged 20-60.
History
- Pain and/or paresthesia in median nerve distribution (i.e., numbness in some combination of digit 1, 2, 3, and the radial part of digit 4)
- Nocturnal pain and/or paresthesia in median nerve distribution
- Symptoms (a and b) greater than 3 months in duration
Physical Exam with two of the following three findings:
- Phalen's and Durkin's sign (positive with paresthesia in at least 1 of 3 radial digits)
- Abnormal grip strength (greater than 2 S.D. compared to uninvolved side using an isometric hand grip device)
Nerve conduction findings consistent with mild to severe CTS:

Mild CTS: Delayed distal latency of the sensory nerve conductions across the wrist (> 3.7milliseconds and/or > than 0.5 milliseconds compared to the ulnar sensory conduction) with normal motor conductions

Moderate CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with delayed distal latency of the motor conductions across the wrist (> 4.2 milliseconds).

Severe CTS: Delayed distal latency of the sensory nerve conductions across the wrist as stated above with greater than 50% loss of motor amplitudes (relative to unaffected side and/or normative range).

Exclusion Criteria:

Contraindications to MRI examination (pregnancy, pacemaker, etc. according to guidelines set by MGH NMR-Center)
History of diabetes mellitus or other major cardiovascular, respiratory, or neurological illnesses.
History of rheumatoid arthritis.
History of wrist fracture with direct trauma to median nerve.
Current usage of prescriptive opioid pain medication.
Severe thenar atrophy.
Nerve entrapment other than median nerve.
Cervical radiculopathy or myelopathy.
Generalized peripheral neuropathy.
A blood dyscrasia or coagulopathy or current use of anticoagulation therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases