Brain 'Radio' tunes into Depression's neural signals
NCT ID NCT01984710
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This study tests a brain implant that can both stimulate and record brain activity in people with treatment-resistant depression. The goal is to capture the brain's electrical signals before and during stimulation to understand how deep brain stimulation (DBS) works to relieve symptoms. By mapping these signals, researchers hope to make DBS more effective and personalized for those who haven't found relief from other treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Deep brain stimulation (DBS) using the Medtronic Activa PC+S device
- What this could lead to
- If successful, this could reveal how deep brain stimulation eases severe depression and lead to more personalized, effective DBS therapy.
- What could go wrong
- This is a small, early-stage study focused on understanding brain signals, not a proven treatment. DBS carries surgical risks, and the benefits for depression are not guaranteed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Sep 2013
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Ability to provide written informed consent. * Agrees to relocate to the Atlanta Metro region for the duration of the acute phase of the investigation (approximately 8-10 months) and to return regularly for clinical and research assessments * Current Major Depressive Episode (MDE), either Major Depressive Disorder single episode or recurrent type * Current depressive episode of at least two years duration or a history of more than 4 lifetime depressive episodes * Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17) * Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30% lower than the baseline screening HDRS-17 score * A maximum Global Assessment of Functioning of 50 or less * Failure to respond to a minimum of four different antidepressant treatments, including at least three medications from at least three different drug classes, evidence-based psychotherapy or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode * Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode * On stable antidepressant medication * Have an established outpatient psychiatrist and be willing to sign a written release to allow study investigators to give and receive information from this psychiatrist Exclusion Criteria: * Inability/ refusal to sign written informed consent * Refusal or inability to relocate to Atlanta Metro region for acute phase of protocol or to return for regular assessments in long term follow up * Inability to tolerate general anesthesia * Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurological disorder * Other currently active clinically significant Axis I psychiatric diagnosis including bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder * Current psychotic symptoms * Evidence of global cognitive impairment * Substance abuse or dependence not in full, sustained remission * Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years * Pregnancy or plan to become pregnant during the study period * General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices) * Inability or unwillingness to comply with long-term follow-up * History of intolerance to neural stimulation of any area of the body * Participation in another drug, device or biologics trial within the preceding 30 days prior to initial screening * Conditions requiring repeated MRI scans * Conditions requiring diathermy * Conditions requiring anticoagulant medication * Terminal illness associated with expected survival of \<12 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University
Atlanta, Georgia, 30322, United States
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Other studies related to the condition(s) this trial covers.
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