Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE

NCT ID: NCT05791812

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-16

Study Completion Date

2026-03-31

Brief Summary

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It is a one-arm open-label interventional study with transcranial direct current stimulation in an remote home-based setting with the aims to evaluate the feasibility (usability of the device, compliance of patients, usability of the teletherapy), the effectiveness (clinical ratings) and the compatability of this intervention in 20 patients with myalgic encephalomyelitis/chronic fatigue syndrome.

Detailed Description

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Conditions

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Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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active treatment

2mA of tDCS for 20 min every weekday for six weeks

Group Type EXPERIMENTAL

home-based transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

2mA of tDCS for 20 min every weekday for six weeks

Interventions

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home-based transcranial direct current stimulation (tDCS)

2mA of tDCS for 20 min every weekday for six weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ME/CFS diagnosis according to the Canadian Consensus Criteria
* residence near Regensburg and mother language German
* written informed consent
* stable medication if possible

Exclusion Criteria

* contraindications for transcranial direct current stimulation
* certain neurological conditions as assessed by study physician
* participation in another study
* pregnancy and lactation period
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Berthold Langguth, MD, Ph.D.

Clinical Professor, MD, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berthold Langguth

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

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Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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22-3028-101

Identifier Type: -

Identifier Source: org_study_id

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