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

• Sponsor: University of Regensburg (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05791812
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 22.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

It is a one-arm open-lable 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.

Condition or Disease	Intervention/Treatment	Phase
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome	Device: home-based transcranial direct current stimulation (tDCS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE - Heimanwendung Der Transkraniellen Gleichstromstimulation Zur Behandlung Der Chronischen Fatigue
• Actual Study Start Date: Mar 16, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Jan 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: active treatment 2mA of tDCS for 20 min every weekday for six weeks	Device: home-based transcranial direct current stimulation (tDCS); 2mA of tDCS for 20 min every weekday for six weeks

Outcome Measures

Primary Outcome Measures

1. Usability for the patients [6 weeks]

   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] and open feedback

2. Usability for the handlers/clinicians [6 weeks]

   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] and open feedback

3. Compliance 1 (Number of days out of 30 the patients used the device) [6 weeks]

   Number of days out of 30 the patients used the device

4. Compliance 2 (Number of patients who completed the treatment regulary) [6 weeks]

   Number of patients who completed the treatment regulary

5. Effectiveness 1 (Number of responders according the the clinical global impression change score for patients in the per protocol analysis) [6 weeks]

   Number of responders according the the clinical global impression change score for patients in the per protocol analysis

6. Effectiveness 2 (Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score) [6 weeks]

   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)

7. Effectiveness 3 (Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale) [6 weeks]

   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

1. Major Depression Inventory [18 weeks]

   Depression inventory (0-50, the lower the better)

2. WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF) [18 weeks]

   Quality of life scale inventory (4-20, the higher the better)

3. Clincial Global Impression change [18 weeks]

   Clincial Global Impression (1-7, the lower the better)

4. Pittsburgh sleep quality index [18 weeks]

   sleep inventory (0-21, the lower the better)

5. numeric analogue scale pain [18 weeks]

   pain scale (0-10, the lower the better)

6. d2 test [18 weeks]

   concentration test (pecentiles; the higher the better)

7. digital span [18 weeks]

   memory test (pecentiles; the higher the better)

8. Chalder fatigue scale [18 weeks]

   fatigue scale (0-33; the lower the better)

9. Bell score [18 weeks]

   fatigue scale (0-100; the higher the better)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• participiation in another study

• pregnancy and lactation period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry and Psychotherapy, University of Regensburg	Regensburg		Germany	93055

Sponsors and Collaborators

• University of Regensburg

Investigators

• Principal Investigator: Berthold Langguth, University of Regensburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Berthold Langguth, MD, Ph.D., Clinical Professor, MD, Ph.D., University of Regensburg
• ClinicalTrials.gov Identifier: NCT05791812
• Other Study ID Numbers: 22-3028-101
• First Posted: Mar 30, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Berthold Langguth, MD, Ph.D., Clinical Professor, MD, Ph.D., University of Regensburg: transcranial direct current stimulation
• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Encephalomyelitis; Fatigue

Study Results

No Results Posted as of Mar 30, 2023