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Not yet recruitingNAINTERVENTIONAL

Dual Neuromodulation for Depression: Boosting TMS With tES

This research is investigating if combining two types of gentle brain stimulation, TMS and tACS, could be a more effective way to help people with depression. TMS is already used for depression, but its results can vary. This study wants to find out if using tACS alongside TMS, by carefully timing when they are given, can make TMS work better. We're especially interested in how this combined approach might improve emotional processing in the brain. It's a small, early-stage study involving up to 60 volunteers over one week. The main goal is to understand how this new combined method affects the brain and to help plan a larger study in the future. It’s not a full treatment yet, but a step towards finding better options.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Mersey Care NHS Trust
Enrolment target
60
Start
01 Sep 2026
Estimated completion
01 Sep 2027

What is this study about?

Many people experience depression, and while there are treatments like Transcranial Magnetic Stimulation (TMS), sometimes they don't work as well for everyone. TMS is a gentle way to stimulate the brain using magnetic pulses, but doctors are always looking for ways to make it more effective. This study is exploring a new idea: what if we combine TMS with another very gentle brain stimulation called Transcranial Alternating Current Stimulation (tACS)?

Think of tACS as a very mild electrical current that helps guide the natural rhythms of your brain activity. The idea is that if we can time the TMS pulses to match these brain rhythms (like playing a musical note at just the right moment in a song), it might help the brain respond better. This study aims to see if this 'synchronised' approach, called tsTMS, can improve how the brain processes emotions and make other positive changes. It's like trying to fine-tune the brain's activity to get a stronger, more helpful response from the TMS.

This is a foundational study, meaning it's an important early step. We're not testing a full treatment yet, but rather trying to understand *how* this combined method works and if it's safe and practical for people. The information we gather will be crucial for designing a larger study in the future, where we can then look at whether this combined approach can be a new, effective treatment for depression.

Key takeaways

  • This study explores combining two gentle brain stimulations (TMS and tACS) for depression.
  • The aim is to see if combining them makes TMS work better, especially for emotional processing.
  • It's a small, early-stage study over one week, not a full treatment for depression.
  • Up to 60 volunteers will take part, receiving one of three types of stimulation.
  • Findings will help design future, larger studies into new depression treatments.
  • Participation involves daily sessions for one week and various assessments.

Who may be eligible?

To take part in this study, you would need to be an adult aged between 18 and 59 years old. You should be able to read and understand English and be able to give your informed consent to participate. We're looking for people who are currently experiencing a moderate episode of depression, as measured by standard questionnaires and interviews. You'd also need to be comfortable with us telling your GP (and mental health team if you have one) about your involvement.

There are also some reasons why you wouldn't be able to join. For example, if you are currently receiving crisis mental health care, or have certain other mental health conditions like a history of bipolar disorder or psychosis. We also can't include people with a high risk of suicide or those who have had seizures or epilepsy. Certain medical devices in your body, like pacemakers, or metal in your head that can't be removed, would also prevent you from taking part. You'd also be unable to join if you are pregnant or have serious skin conditions on your scalp.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you aged between 18 and 59?
  2. Do you have a current moderate depressive episode?
  3. Are you able to read and understand English?
  4. Do you have any metal implants in your head or a pacemaker?
  5. Have you ever had seizures or epilepsy?
  6. Are you currently pregnant or trying to conceive?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive five daily brain stimulation sessions over one week. Each session involves sitting comfortably while two types of gentle brain stimulation (TMS and tACS) are applied to your head using coils and small pads. During these sessions, some people will receive the combined active treatment, while others will receive active TMS with a 'dummy' tACS, which feels similar but isn't active.

Before and after these sessions, you'll have some assessments. These will include questionnaires about your mood and feelings, computer tasks to check how you process emotions and your thinking skills, and potentially brain scans using EEG (which involves wearing a cap with sensors on your head to measure brain waves). There's also an optional part where you might wear a digital device to collect extra information.

We will also ask you about your experience, like how comfortable you found the treatments. There are no medications involved in the study itself, but you would continue with any existing medications prescribed by your doctor. The total time commitment for the study is roughly one week for the daily sessions, plus initial screening and follow-up assessments.

Potential risks and benefits

While there's no guarantee of direct benefit for your depression from this study, the information gained could help us develop better treatments for depression in the future. You might also find participating in research interesting and rewarding. The main risks involve mild side effects from the brain stimulation, such as headaches, discomfort on the scalp, or a slight twitching of facial muscles, which are usually temporary and mild. There's a very rare risk of seizures with TMS, but strict safety measures are in place to minimise this. The mild electrical current from tACS can cause a tingling sensation. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

  • Mersey Care Mood Clinic at Knowsley Resource and Recovery Centre
    Verified postcode
    Liverpool, United Kingdom
  • Mersey Care Mood Clinic at Knowsley Resource and Recovery Centre
    Verified postcode
    Liverpool, United Kingdom

Common questions

What is TMS?

TMS (Transcranial Magnetic Stimulation) is a non-invasive treatment that uses magnetic pulses to stimulate specific areas of the brain, often used for depression.

What is tACS?

tACS (Transcranial Alternating Current Stimulation) is a very gentle electrical current applied to the scalp that aims to influence the brain's natural rhythms.

Will this study cure my depression?

This study is an early-stage investigation to understand how a new combined brain stimulation works. It's not designed as a full treatment course, but the findings will help develop future treatments.

What does 'sham tACS' mean?

'Sham tACS' is like a placebo; it feels similar to the real tACS but doesn't deliver the active stimulation. This helps us fairly compare the effects of the active treatment.

Is the brain stimulation painful?

Most people find the brain stimulation to be tolerable. You might feel a tapping sensation on your head with TMS, and a tingling or itching sensation on your scalp with tACS. Any discomfort is usually mild and temporary.

How to find out more

Yue Peng

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Dual Neuromodulation for Depression: Boosting TMS With tES…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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