Cerebral Changes Following CTS Treated With Guided Plasticity

Study Overview
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Brief Summary
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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.

Official Title
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Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: EMLA® adjuvant
* Behavioral: Sensory training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EMLA®<br>adjuvant forearm anesthesia cream (EMLA®) and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity | Other: EMLA® adjuvant<br>* cutaneous forearm deafferentation<br>Behavioral: Sensory training<br>* Sensibility training of the median nerve<br>|
| Placebo Comparator: Skin cream<br>skin cream and sensibility training in a program involving 15 sessions (8 weeks) of guided plasticity training | Behavioral: Sensory training<br>* Sensibility training of the median nerve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Carpal Tunnel Syndrome Symptom Severity Score | score between 1 and 5, with higher scores indicating worse symptoms or function | 8 weeks | 
| 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) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quick-DASH upper extremity symptom score | score between 1-5, higher scores indicating less symptoms | 8 weeks | 
| 2 Point Discrimination (2PD) | mean value of 3 measures indicating touch threshold | 8 weeks | 
| Sensory conduction velocity | Sensory Nerve Conduction Velocity from nerve conduction studies | 8 weeks | 
| Sensory conduction amplitude | Sensory Nerve Conduction Amplitude from nerve conduction studies | 8 weeks | 
| functional MRI dig 1+2 | comparison between activation using interaction contrast in S1sensory cortex of the | 8 weeks | 
| functional MRI dig 5 | comparison between activation in the sensory cortex of the little finger (EMLA® vs placebo) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Somatosensory Cortex, Anesthesia, Hand