Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500533
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Combining rTMS and tDCS in Depression an Exploratory Clinical Trial
Sponsor:
Regionspsykiatrien Gødstrup
Organization:
Regionspsykiatrien Gødstrup
Study Overview
Official Title:
Combined rTMStDCS in Unipolar Depression an Exploratory Open-label Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CombTMS
Brief Summary:
The investigators aim to conduct a single-arm open-label clinical trial meaning that the investigators will be administering a treatment protocol to one group of patients where no information is withheld from trial participants
The treatment being researched will consist of a rTMStDCS combined 30-session protocol consisting of 15 rTMS sessions every other day alternating with 15 tDCS at-home treatments Treatment sessions will occur from Monday to Friday
rTMS Repetitive Transcranial Magnetic Stimulation is a non-invasive physical treatment which uses pulsing magnetic fields to activate or suppress the brain centres associated with medical and psychiatric disorders thus treating the brain circuits involved in the patients condition tDCS transcranial direct current stimulation is a form of neuromodulation that uses constant low direct current delivered via electrodes on the head
The investigators aim to recruit 40 patients with difficult to treat unipolar depression Patients will be selected among the referrals to the psychiatry department in Gødstrup and to the psychiatry department in Randers
rTMS treatment will be administered by the experienced nurses of the rTMS clinic of each department The TMS treatment will profit from ongoing supervision by the Clinical Directors of each rTMS clinic tDCS will be performed at home by the patients
The study itself will last 30 days per patient where rTMS will be administered on odd numbered days study day 1 3 5 7 29 and tDCS on even numbered days study day 2 4 6 8 30 All patients will start with rTMS and finish with home-based tDCS treatment Both rTMS and tDCS treatments will be administered during working days from Monday to Friday The trial itself is expected to last no more than two years
The goal of this study then is to examine the effectiveness of this combined neuromodulation intervention which has the advantage of reducing the attendance requirements for TMS treatment by 50
The treatment being researched will consist of a rTMStDCS combined 30-session protocol consisting of 15 rTMS sessions every other day alternating with 15 tDCS at-home treatments Treatment sessions will occur from Monday to Friday
rTMS Repetitive Transcranial Magnetic Stimulation is a non-invasive physical treatment which uses pulsing magnetic fields to activate or suppress the brain centres associated with medical and psychiatric disorders thus treating the brain circuits involved in the patients condition tDCS transcranial direct current stimulation is a form of neuromodulation that uses constant low direct current delivered via electrodes on the head
The investigators aim to recruit 40 patients with difficult to treat unipolar depression Patients will be selected among the referrals to the psychiatry department in Gødstrup and to the psychiatry department in Randers
rTMS treatment will be administered by the experienced nurses of the rTMS clinic of each department The TMS treatment will profit from ongoing supervision by the Clinical Directors of each rTMS clinic tDCS will be performed at home by the patients
The study itself will last 30 days per patient where rTMS will be administered on odd numbered days study day 1 3 5 7 29 and tDCS on even numbered days study day 2 4 6 8 30 All patients will start with rTMS and finish with home-based tDCS treatment Both rTMS and tDCS treatments will be administered during working days from Monday to Friday The trial itself is expected to last no more than two years
The goal of this study then is to examine the effectiveness of this combined neuromodulation intervention which has the advantage of reducing the attendance requirements for TMS treatment by 50
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None