Transcutaneous spinal direct current stimulation in symptomatic management of patients with diabetic polyneuropathy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013525

Enrollment

Registered

2018-03-13

Start date

2018-03-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G63.2

Interventions

Group 1: Anodal stimulation tsDCS (20min, 2,5mA) for 50 patients with dPN (diabetic polyneuropathy) in a crossover-Design. Results of pain questionnaires as well as results of a clinical examination (

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Voluntariness; age >18 years at time of examination; proficient german language skils; ability to fully understand the type and purpose of this study; ability to cooperate with the research-team and fulfill all requirements of the study; diabetes mellitus with diabetic polyneuropathy and: 1. pain in the lower extremity or paresthesia in the lower extremity and 2. HbA1c <8,5% (recorded in the last six weeks); informed consent (written).

Exclusion criteria

Exclusion criteria: Withdrawal of the informed consent; psychiatric disease; neurological comorbidity; change in medication in the preceding six weeks (e.g. antidiabetics, antidepressants, analgetics or other centrally active substances); employees of the principal investigator who is conducting and/or participating in this or in other studies; needle EMG: wound healing disorders, diabetic foot syndrome; cardiac pacemaker; secondary exclusion criteria: change in medication between the two examinations.

Design outcomes

Primary

Measure	Time frame
Intensity of pain in patients affected by dPN, measured by Numeric Rating Scale (NRS 0-10), during the control-examination directly after stimulation, 30 min and 24h later.	—

Secondary

Measure	Time frame
Degree of paresthesia in patients (Score 0-10 with the paresthesia questionaire, quality of sleep (equal, better, worse) and sensibility with the NDS-Score and a clinical examination are examined directly, 30min and 24h after stimulation.	—

Countries

Germany

Contacts

Public ContactChristine Meyer-Frießem

Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum

meyer-friessem@ains-bergmannsheil.de0049234-3020

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026