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Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain

NCT06152887 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-01

No results posted yet for this study

Summary

To investigate whether transcranial direct current stimulation can alleviate pain and sensory related disturbances in individuals with type 1 diabetes and peripheral neuropathy through neuromodulation of the CNS as compared to sham treatment.

Conditions

  • Diabetic Neuropathy, Painful
  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Sooma Oy (tDCS), Helsinki, Finland

Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1)

DEVICE

Sooma Oy (Sham), Helsinki, Finland

For the sham treatment, an electrical current will also be increased from 0 mA to 2 mA over the first 30 seconds, however, the current will be ramped back down to 0 mA after the initial ramp-up phase and no stimulation is delivered for the rest of the treatment.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Vissing fonden

    collaborator UNKNOWN

  • Jens Brøndum Frøkjær

    lead OTHER

Principal Investigators

  • Jens Brøndum Frøkjær, MD, Ph.D · Professor and Chief Physician at Aalborg University Hospital, Department of Radiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06152887 on ClinicalTrials.gov