Major DepressionCombTMSNCT06500533
Combining rTMS and tDCS in Depression: an Exploratory Clinical Trial
A study testing rTMS combined with tDCS in people with Major Depression and Treatment Resistant Depression, run by Regionspsykiatrien Gødstrup at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Major Depression, Treatment Resistant Depression
- What is being tested?
- rTMS combined with tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Jul 2024to 19 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, between 22 and 80 years of age.
- Able to provide informed consent.
- Primary diagnosis of depressive episode (F32) or recurrent depressive disorder (F33), according to International Classification of Diseases 10th Revision (ICD-10).
- Simultaneous fulfillment of diagnostic criteria for Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE), according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Currently experiencing moderate to severe depressive episodes (scores ≥20 on the 17-item Hamilton Depression Rating Scale [HAM-D 17]).
Who cannot join
- Primary psychiatric diagnosis other than single episode depressive disorder or recurrent depressive disorder.
- History of schizophrenia or schizoaffective disorders.
- Any history of psychotic symptoms in the current or previous depressive episodes.
- History of obsessive-compulsive disorder.
- History of autism spectrum disorder.
- History of intractable migraine.
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- Clinical conditions that would increase risks associated with receiving high-dose iTBS.
- Cochlear implants.
- Epilepsy.
- Pacemakers.
- Presence of metal in the head, especially of a ferromagnetic type.
- Presence of magnetically controlled implantable devices.
- Current drug misuse (F10-F19).
- History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
- Current (or chronic) use of opiates.
- Prior nonresponse to rTMS.
- Prior nonresponse to Electroconvulsive Therapy (ECT).
- Female that is pregnant or breastfeeding.
- Female with a positive pregnancy test at participation.
- History of psychosurgery for depression.
- Damage to- or diseases of the skin, which affects the scalp. E.g. Psoriasis or open wounds.
- No changes in psychotropic medication during the study will be allowed, with the exception of the ones due to intolerability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined rTMS/tDCS in Unipolar Depression: an Exploratory Open-label Trial
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 rTMS/tDCS 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.
Read more
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 patient's 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%.
- Conditions
- Major Depression, Treatment Resistant Depression
- Being tested
- rTMS combined with tDCS
- Keywords
- unipolar depression, rTMS, tDCS, neuromodulation, treatment resistant depression, difficult-to-treat depression
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS combined with tDCSDevice
The intervention 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 TMS and finish with home-based tDCS treatment. Both rTMS and tDCS treatments will be administered during working days, from Monday to Friday.
rTMS treatment will be administered by the experienced nurses of the rTMS clinic of each department. The rTMS treatment will profit from ongoing supervision by the Clinical Directors of each TMS clinic, which is in line with treatment as usual.
tDCS will be performed at home by the patients.
| Study group | Role | What they receive |
|---|---|---|
| Study's single arm | Experimental | Patients will be receiving rTMS/tDCS combined 30-session protocol, consisting of 15 rTMS sessions every other day alternating with 15 tDCS at-home treatments.
The rTMS protocol used in the study will be intermittent Theta Burst Stimulation (iTBS) on the left dorsolateral prefrontal cortex given for 3 minutes and 9 seconds, every other day 5 weeks. iTBS is delivered in 2s bursts consisting of three pulses at a frequency of 50 Hz, with an inter-burst interval of 200 ms (i.e., 5 Hz). Stimulation intensity will be 120% of resting motor threshold.
Each of the 15 tDCS sessions will be lasting 30 minutes with a stimulation intensity of 2mA. The electrodes will be positioned bilaterally over the dorsolateral prefrontal cortex. The device chosen for the study is specifically designed for home use. The device is controlled via an app that walks the participant through correct usage and dosage with the device to minimize non-compliance. Receives: Device: rTMS combined with tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D17 scores
Our primary outcome measure will be Hamilton Depression Rating Scale, 17-item version (HAM-D17) scores at the end of the 30th treatment session normalized to baseline.
Measured: Baseline, and end of the 30th treatment session.
Secondary outcomes (1)
HAM-D17 scores at week 9 and MDI scores
Changes in HAM-D17 scores from baseline to 4 weeks after the last treatment (study week 9) will be a secondary outcome.
HAM-D17 scores will be used to calculate response and remission rates in each group:
- Response: reduction ≥50% in HAM-D17
- Remission: HAM-D17 scores ≤7
Our secondary outcome will also include changes in scores on the MDI will be used as a secondary measure of depression severity (30th session; 4 weeks after the 30th session), normalized to baseline. MDI scores will be used to calculate response and remission rates in each group:
- Response: reduction ≥50% in MDI
- Remission: MDI scores ≤20
Response and remission at a single time point
- Participants will be identified as responders or remitters if they met these specific criteria at day 30.
- Participants will be identified as long-term responders or remitters if they meet these specific criteria at both study day 30 and study week 9 (e.g., 4 weeks after the end of treatment)
Measured: Baseline, end of the 30th treatment session and 4 weeks after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start31 Jul 2024
- Primary completion19 May 2025
- Study completion19 May 2025
Why it stopped: The Principal Investigator left the institution, resulting in the inability to maintain necessary conditions for study continuation. Sufficient data were collected for scientific analysis, but not all planned data were obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionspsykiatrien Gødstrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro C Barata, MD, Principal investigator, Regionspsykiatrien Gødstrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500533
- Sponsor's protocol ID
- Open label TMS
- Acronym
- CombTMS
- Status last verified
- May 2025
- First submitted
- 8 Jul 2024
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined rTMS/tDCS in Unipolar Depression: an Exploratory Open-label Trial
- ClinicalTrials.gov ID
- NCT06500533
- Acronym / sponsor ID
- CombTMS / Open label TMS
- Conditions
- Major Depression, Treatment Resistant Depression
- Keywords
- unipolar depression, rTMS, tDCS, neuromodulation, treatment resistant depression, difficult-to-treat depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Principal Investigator left the institution, resulting in the inability to maintain necessary conditions for study continuation. Sufficient data were collected for scientific analysis, but not all planned data were obtained.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Regionspsykiatrien GødstrupUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 rTMS/tDCS 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 patient's 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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study's single arm | Experimental | Device: rTMS combined with tDCSPatients will be receiving rTMS/tDCS combined 30-session protocol, consisting of 15 rTMS sessions every other day alternating with 15 tDCS at-home treatments. The rTMS protocol used in the study will be intermittent Theta Burst Stimulation (iTBS) on the left dorsolateral prefrontal cortex given for 3 minutes and 9 seconds, every other day 5 weeks. iTBS is delivered in 2s bursts consisting of three pulses at a frequency of 50 Hz, with an inter-burst interval of 200 ms (i.e., 5 Hz). Stimulation intensity will be 120% of resting motor threshold. Each of the 15 tDCS sessions will be lasting 30 minutes with a stimulation intensity of 2mA. The electrodes will be positioned bilaterally over the dorsolateral prefrontal cortex. The device chosen for the study is specifically designed for home use. The device is controlled via an app that walks the participant through correct usage and dosage with the device to minimize non-compliance. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, between 22 and 80 years of age.
- Able to provide informed consent.
- Primary diagnosis of depressive episode (F32) or recurrent depressive disorder (F33), according to International Classification of Diseases 10th Revision (ICD-10).
- Simultaneous fulfillment of diagnostic criteria for Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE), according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Currently experiencing moderate to severe depressive episodes (scores ≥20 on the 17-item Hamilton Depression Rating Scale [HAM-D 17]).
Key exclusion criteria (22 listed)
- Primary psychiatric diagnosis other than single episode depressive disorder or recurrent depressive disorder.
- History of schizophrenia or schizoaffective disorders.
- Any history of psychotic symptoms in the current or previous depressive episodes.
- History of obsessive-compulsive disorder.
- History of autism spectrum disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS combined with tDCSThe intervention 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 TMS and finish with home-based tDCS treatment. Both rTMS and tDCS treatments will be administered during working days, from Monday to Friday. rTMS treatment will be administered by the experienced nurses of the rTMS clinic of each department. The rTMS treatment will profit from ongoing supervision by the Clinical Directors of each TMS clinic, which is in line with treatment as usual. tDCS will be performed at home by the patients. | Device | Study's single arm |
Primary outcome
HAM-D17 scores
Time frame: Baseline, and end of the 30th treatment session.
Our primary outcome measure will be Hamilton Depression Rating Scale, 17-item version (HAM-D17) scores at the end of the 30th treatment session normalized to baseline.
1 secondary outcome
HAM-D17 scores at week 9 and MDI scores
Time frame: Baseline, end of the 30th treatment session and 4 weeks after the last treatment.
Results and safety
The study was stopped early (reason given: The Principal Investigator left the institution, resulting in the inability to maintain necessary conditions for study continuation. Sufficient data were collected for scientific analysis, but not all planned data were obtained.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro C Barata, MD principal investigator
Regionspsykiatrien Gødstrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS combined with tDCS in people with Major Depression and Treatment Resistant Depression, run by Regionspsykiatrien Gødstrup at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The Principal Investigator left the institution, resulting in the inability to maintain necessary conditions for study continuation. Sufficient data were collected for scientific analysis, but not all planned data were obtained.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAM-D17 scores (time frame: Baseline, and end of the 30th treatment session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.