Back to results

Cerebral Changes Following CTS Treated With Guided Plasticity

Primary Purpose

Carpal Tunnel Syndrome

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

EMLA® adjuvant

Sensory training

About this trial

This is an interventional basic science trial for Carpal Tunnel Syndrome focused on measuring Magnetic Resonance Imaging, Somatosensory Cortex, Anesthesia, Hand

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: symptoms of CTS for more than 3 months classic or probable CTS according to Katz' hand diagram (2, 27) clinical signs of unilateral CTS with a positive Tinel's and Phalen's test age between 18 and 70 years nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side no contraindications for MR examinations. Exclusion Criteria: bilateral symptoms having been operated for CTS previously prior wrist or carpal fracture diabetes thyroid disease rheumatoid arthritis neurological disease drug abuse complete conduction block on electroneurography or prior regular exposure to hand-held vibrating tools.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EMLA®

Skin cream

Arm Description

adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity

skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training

Outcomes

Primary Outcome Measures

Boston Carpal Tunnel Syndrome Symptom Severity Score

score between 1 and 5, with higher scores indicating worse symptoms or function

functional MRI activation affected vs healthy side (more activation voxels means more active brain area)

The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)

Secondary Outcome Measures

quick-DASH upper extremity symptom score

score between 1-5, higher scores indicating less symptoms

2 Point Discrimination (2PD)

mean value of 3 measures indicating touch threshold

Sensory conduction velocity

Sensory Nerve Conduction Velocity from nerve conduction studies

Sensory conduction amplitude

Sensory Nerve Conduction Amplitude from nerve conduction studies

functional MRI dig 1+2

comparison between activation using interaction contrast in S1sensory cortex of the

functional MRI dig 5

comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)

Full Information

NCT ID

NCT06016049

First Posted

June 11, 2023

Last Updated

August 24, 2023

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT06016049

Brief Title

Cerebral Changes Following CTS Treated With Guided Plasticity

Official Title

Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2009 (Actual)

Primary Completion Date

November 1, 2015 (Actual)

Study Completion Date

November 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Region Skane

4. Oversight

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH). Clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

Keywords

Magnetic Resonance Imaging, Somatosensory Cortex, Anesthesia, Hand

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EMLA®

Arm Type

Active Comparator

Arm Description

adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity

Arm Title

Skin cream

Arm Type

Placebo Comparator

Arm Description

skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training

Intervention Type

Other

Intervention Name(s)

EMLA® adjuvant

Intervention Description

cutaneous forearm deafferentation

Intervention Type

Behavioral

Intervention Name(s)

Sensory training

Intervention Description

Sensibility training of the median nerve

Primary Outcome Measure Information:

Title

Boston Carpal Tunnel Syndrome Symptom Severity Score

Description

score between 1 and 5, with higher scores indicating worse symptoms or function

Time Frame

8 weeks

Title

functional MRI activation affected vs healthy side (more activation voxels means more active brain area)

Description

The difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

quick-DASH upper extremity symptom score

Description

score between 1-5, higher scores indicating less symptoms

Time Frame

8 weeks

Title

2 Point Discrimination (2PD)

Description

mean value of 3 measures indicating touch threshold

Time Frame

8 weeks

Title

Sensory conduction velocity

Description

Sensory Nerve Conduction Velocity from nerve conduction studies

Time Frame

8 weeks

Title

Sensory conduction amplitude

Description

Sensory Nerve Conduction Amplitude from nerve conduction studies

Time Frame

8 weeks

Title

functional MRI dig 1+2

Description

comparison between activation using interaction contrast in S1sensory cortex of the

Time Frame

8 weeks

Title

functional MRI dig 5

Description

comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magnus Flondell, MD PhD

Organizational Affiliation

Institute of Translational Sciences Malmö, Lund University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anders Björkman, MD, Prof.

Organizational Affiliation

Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

data can be shared upon reasonable demand after personal contact.

Learn more about this trial

Cerebral Changes Following CTS Treated With Guided Plasticity

We'll reach out to this number within 24 hrs