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

Primary Purpose

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
home-based transcranial direct current stimulation (tDCS)
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome focused on measuring transcranial direct current stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of RegensburgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Usability for the patients
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better]
Usability for the handlers/clinicians
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better]
Number of days out of 30 the patients used the device
Number of days out of 30 the patients used the device
Number of patients who completed the treatment regularly
Number of patients who completed the treatment regularly
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Number of responders according the the clinical global impression change score for patients in the per protocol analysis (range: 1-7; the lower the better)
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score (fatigue scale; 0-100; the higher the better)
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale (fatigue scale; 0-33; the lower the better)

Secondary Outcome Measures

Major Depression Inventory
Depression inventory (0-50, the lower the better)
World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Quality of life scale inventory (4-20, the higher the better)
Clinical Global Impression change
Clinical Global Impression (1-7, the lower the better)
Pittsburgh sleep quality index
sleep inventory (0-21, the lower the better)
numeric analogue scale pain
pain scale (0-10, the lower the better)
d2 test
concentration test (percentiles; the higher the better)
digital span
memory test (percentiles; the higher the better)
Chalder fatigue scale
fatigue scale (0-33; the lower the better)
Bell score
fatigue scale (0-100; the higher the better)

Full Information

First Posted
March 17, 2023
Last Updated
April 4, 2023
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT05791812
Brief Title
Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE
Acronym
ACTIVATE
Official Title
Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE - Heimanwendung Der Transkraniellen Gleichstromstimulation Zur Behandlung Der Chronischen Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Keywords
transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active treatment
Arm Type
Experimental
Arm Description
2mA of tDCS for 20 min every weekday for six weeks
Intervention Type
Device
Intervention Name(s)
home-based transcranial direct current stimulation (tDCS)
Intervention Description
2mA of tDCS for 20 min every weekday for six weeks
Primary Outcome Measure Information:
Title
Usability for the patients
Description
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better]
Time Frame
6 weeks
Title
Usability for the handlers/clinicians
Description
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire [1-7, 26 items, the higher the better]
Time Frame
6 weeks
Title
Number of days out of 30 the patients used the device
Description
Number of days out of 30 the patients used the device
Time Frame
6 weeks
Title
Number of patients who completed the treatment regularly
Description
Number of patients who completed the treatment regularly
Time Frame
6 weeks
Title
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Description
Number of responders according the the clinical global impression change score for patients in the per protocol analysis (range: 1-7; the lower the better)
Time Frame
6 weeks
Title
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score
Description
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score (fatigue scale; 0-100; the higher the better)
Time Frame
6 weeks
Title
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale
Description
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale (fatigue scale; 0-33; the lower the better)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Major Depression Inventory
Description
Depression inventory (0-50, the lower the better)
Time Frame
18 weeks
Title
World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Description
Quality of life scale inventory (4-20, the higher the better)
Time Frame
18 weeks
Title
Clinical Global Impression change
Description
Clinical Global Impression (1-7, the lower the better)
Time Frame
18 weeks
Title
Pittsburgh sleep quality index
Description
sleep inventory (0-21, the lower the better)
Time Frame
18 weeks
Title
numeric analogue scale pain
Description
pain scale (0-10, the lower the better)
Time Frame
18 weeks
Title
d2 test
Description
concentration test (percentiles; the higher the better)
Time Frame
18 weeks
Title
digital span
Description
memory test (percentiles; the higher the better)
Time Frame
18 weeks
Title
Chalder fatigue scale
Description
fatigue scale (0-33; the lower the better)
Time Frame
18 weeks
Title
Bell score
Description
fatigue scale (0-100; the higher the better)
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Hebel
Phone
+49-941-1250
Email
tobias.hebel@medbo.de
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Schecklmann
Phone
+49-941-1250
Email
martin.schecklmann@medbo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Regensburg
City
Regensburg
ZIP/Postal Code
93055
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth
Phone
+49-941-941-2099
Email
berthold.langguth@medbo.de

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
On demand possible.

Learn more about this trial

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

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