Bipolar DisorderNCT03622749
Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
A study testing Transcranial Magnetic Stimulation (TMS) in people with Bipolar Disorder and Transcranial Magnetic Stimulation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if the study can use a technique called "transcranial magnetic stimulation" or TMS to help improve emotion regulation for individuals with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Transcranial Magnetic Stimulation
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients
- Men and women
- Ages 18-50 years
- Patients diagnosed with bipolar I disorder (BD-I), current mood state euthymic.
- On a stable psychiatric medication regimen for at least a month prior to and during study participation
- Healthy Controls:
Show all 9Show fewer
- Men and women
- Ages 18-50 years
- Without major psychiatric illness
Who cannot join
- Patients
- Any change in psychiatric medications within a month prior to and during study participation
- Legal or mental incompetency
- Intellectual disability
- Current manic (YMRS > 12) or severe depressive episode (HAM-D-17 > 5)
- Substance use disorder (abuse or dependence) with active use within the last 3 months
Show all 45Show fewer
- Significant medical or neurological illness
- Prior neurosurgical procedure
- History of seizures
- History of ECT treatment or clinical TMS within the past three months
- Implanted cardiac pacemakers
- Patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or neck, or are non-removable and within 30 cm of the treatment coil. These include:
- Aneurysm clips or coils
- Carotid or cerebral stents
- Metallic devices implanted in the head (e.g. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt)
- Magnetically active dental implants
- Cochlear/otologic implants
- CSF shunts
- Ferromagnetic ocular implants
- Pellets, bullets, fragments less than 30 cm from the coil
- Facial tattoos with metallic ink, permanent makeup less than 30 cm from the coil
- Pregnant women
- Healthy Controls:
- History of major psychiatric illness, including psychosis
- Has a first-degree relative with psychosis
- Active use of neuropsychoactive medications
- Legal or mental incompetency
- Intellectual disability
- Substance use disorder (abuse or dependence) with active use within the last 3 months
- Significant medical or neurological illness
- Prior neurosurgical procedure
- History of seizures
- History of ECT treatment or clinical TMS within the past three months
- Implanted cardiac pacemakers
- Individuals who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or neck, or are non-removable and within 30 cm of the treatment coil. These include:
- Aneurysm clips or coils
- Carotid or cerebral stents
- Metallic devices implanted in the head (e.g. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt)
- Magnetically active dental implants
- Cochlear/otologic implants
- CSF shunts
- Ferromagnetic ocular implants
- Pellets, bullets, fragments less than 30 cm from the coil
- Facial tattoos with metallic ink, permanent makeup less than 30 cm from the coil
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, 02129
About this study
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if the study can use a technique called "transcranial magnetic stimulation" or TMS to help improve emotion regulation for individuals with bipolar disorder.
Read the detailed description
Emotion dysregulation contributes to the development and maintenance of a wide range of psychopathology, but is especially relevant for individuals with bipolar mood disorders (BD). These individuals experience severe and episodic emotion dysregulation associated with maladaptive functioning, interpersonal problems, decreased work productivity, and suicidal ideation and behavior. To date, both pharmacological and psychosocial treatments fail to normalize emotion dysregulation for many bipolar patients. As a consequence, all too many experience poor outcomes. Thus, there is a significant need for new innovative approaches to target and improve emotion dysregulation in bipolar patients. Non-invasive neuromodulation using transcranial magnetic stimulation (TMS) may provide a viable strategy to help improve emotion dysregulation in bipolar mood disorders. As a first step to test this hypothesis, the current proposal seeks to experimentally identify specific neural target sites for improving emotion regulation using TMS. If the investigators can demonstrate target engagement of emotion regulation at the behavioral level using TMS, this will provide an important first step towards examining the potential utility of TMS as a viable strategy to help improve emotion dysregulation in bipolar mood disorders. While this is not a definitive clinical trial, the sham-controlled double-crossover design of this study will provide valuable information for target site selection for the development of TMS as an intervention strategy to improve emotion dysregulation in BD.
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
Non-Invasive neuromodulation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Active comparator | Individuals with Bipolar 1 Disorder Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affective Multisource Interference Task - Reaction Time During Negative Interference Trials
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 1: Slope of reaction time during trials with negative valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Measured: Task administered 10 minutes pre TMS and 5 minutes post TMS
Affective Multisource Interference Task - Reaction Time During Positive Interference Trials
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 2: Slope of reaction time during trials with positive valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Measured: Task administered 10 minutes pre TMS and 5 minutes post TMS
Emotion Conflict Resolution Task - Incongruent Fear Trials Reaction Time
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 3: Slope of reaction time during trials when the image is of a fearful facial expression but the word is "Happy" (incongruent)
Measured: Task administered 10 minutes pre TMS and 5 minutes post TMS
Emotion Conflict Resolution Task - Incongruent Happy Trials Reaction Time
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 4: Slope of reaction time during trials when the image is of a happy facial expression but the word is "Fear" (incongruent)
Measured: Task administered 10 minutes pre TMS and 5 minutes post TMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Mar 2019
- Primary completion1 Aug 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen K. Ellard, Ph.D., Massachusetts General Hospital
- Investigators
- Kristen K Ellard, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622749
- Sponsor's protocol ID
- 2018P001227
- Other IDs
- 1T32NS100663-01
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2018
- Last updated
- 3 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
- ClinicalTrials.gov ID
- NCT03622749
- Acronym / sponsor ID
- 2018P001227
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 3 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if the study can use a technique called "transcranial magnetic stimulation" or TMS to help improve emotion regulation for individuals with bipolar disorder.
Detailed description
Emotion dysregulation contributes to the development and maintenance of a wide range of psychopathology, but is especially relevant for individuals with bipolar mood disorders (BD). These individuals experience severe and episodic emotion dysregulation associated with maladaptive functioning, interpersonal problems, decreased work productivity, and suicidal ideation and behavior. To date, both pharmacological and psychosocial treatments fail to normalize emotion dysregulation for many bipolar patients. As a consequence, all too many experience poor outcomes. Thus, there is a significant need for new innovative approaches to target and improve emotion dysregulation in bipolar patients. Non-invasive neuromodulation using transcranial magnetic stimulation (TMS) may provide a viable strategy to help improve emotion dysregulation in bipolar mood disorders. As a first step to test this hypothesis, the current proposal seeks to experimentally identify specific neural target sites for improving emotion regulation using TMS. If the investigators can demonstrate target engagement of emotion regulation at the behavioral level using TMS, this will provide an important first step towards examining the potential utility of TMS as a viable strategy to help improve emotion dysregulation in bipolar mood disorders. While this is not a definitive clinical trial, the sham-controlled double-crossover design of this study will provide valuable information for target site selection for the development of TMS as an intervention strategy to improve emotion dysregulation in BD.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)Individuals with Bipolar 1 Disorder |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients
- Men and women
- Ages 18-50 years
- Without major psychiatric illness
Key exclusion criteria (45 listed)
- Patients
- History of major psychiatric illness, including psychosis
- Has a first-degree relative with psychosis
- Active use of neuropsychoactive medications
- Legal or mental incompetency
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)Non-Invasive neuromodulation | Device | Patients |
Primary outcome
Affective Multisource Interference Task - Reaction Time During Negative Interference Trials
Time frame: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 1: Slope of reaction time during trials with negative valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Affective Multisource Interference Task - Reaction Time During Positive Interference Trials
Time frame: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 2: Slope of reaction time during trials with positive valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box
Emotion Conflict Resolution Task - Incongruent Fear Trials Reaction Time
Time frame: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 3: Slope of reaction time during trials when the image is of a fearful facial expression but the word is "Happy" (incongruent)
Emotion Conflict Resolution Task - Incongruent Happy Trials Reaction Time
Time frame: Task administered 10 minutes pre TMS and 5 minutes post TMS
The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 4: Slope of reaction time during trials when the image is of a happy facial expression but the word is "Fear" (incongruent)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kristen K Ellard, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Bipolar Disorder and Transcranial Magnetic Stimulation, run by Massachusetts General Hospital at 1 site in United States.
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 9 inclusion and 45 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: finished, as of the sponsor's last update on 3 Mar 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Affective Multisource Interference Task - Reaction Time During Negative Interference Trials (time frame: Task administered 10 minutes pre TMS and 5 minutes post TMS). The study lists 4 primary outcomes in all. 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 3 Mar 2026.