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Cerebral Changes Following CTS Treated With Guided Plasticity

Cerebral Changes Following Carpal Tunnel Syndrome Treated With Guided Brain Plasticity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06016049
Enrollment
70
Registered
2023-08-29
Start date
2009-07-01
Completion date
2015-11-01
Last updated
2023-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Magnetic Resonance Imaging, Somatosensory Cortex, Anesthesia, Hand

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.

Interventions

OTHEREMLA® adjuvant

cutaneous forearm deafferentation

Sensibility training of the median nerve

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Boston Carpal Tunnel Syndrome Symptom Severity Score8 weeksscore 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)8 weeksThe difference in activation using interaction contrast between baseline vs 8 weeks in somatosensory cortex (affected vs healthy side)

Secondary

MeasureTime frameDescription
Sensory conduction velocity8 weeksSensory Nerve Conduction Velocity from nerve conduction studies
Sensory conduction amplitude8 weeksSensory Nerve Conduction Amplitude from nerve conduction studies
quick-DASH upper extremity symptom score8 weeksscore between 1-5, higher scores indicating less symptoms
functional MRI dig 58 weekscomparison between activation in the sensory cortex of the little finger (EMLA® vs placebo)
functional MRI dig 1+28 weekscomparison between activation using interaction contrast in S1sensory cortex of the
2 Point Discrimination (2PD)8 weeksmean value of 3 measures indicating touch threshold

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026