ManiaBPD_DBSNCT05444907
Deep Brain Stimulation-Induced Mania in Parkinson's Disease
An observational study of Mania and Parkinson Disease, run by Albino Maia at 1 site in Portugal.
Trial summary
Parkinson's Disease (PD) is a common and debilitating neurodegenerative disease. While medication can alleviate its symptoms, not all patients will adequately respond to medical therapy. For these cases, deep brain stimulation (DBS) has been used to improve symptoms and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mania, Parkinson Disease
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 25 May 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort will be collected retrospectively from DBS surgery databases from different Movement Disorders and Functional Surgery Groups and further analyzed at the Champalimaud Neuropsychiatry Unit. Data collection will be conducted by each center independently under the approval of their respective Ethics Committees. The data that will be analyzed in this project, including neuroimages, has been collected according to the usual clinical practice of the Movement Disorders and Functional Surgery Groups.
Who may be able to join
- Age≥18-years-old;
- Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target;
- Manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters.
Who cannot join
- Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state before the age of 18
- Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state, before DBS surgery.
- DBS Control Cohort:
- A control cohort will also be collected. These patients will also meet the aforementioned inclusion and exclusion criteria with the exception of not having presented a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Champalimaud Foundation
Lisbon, 1400-038
Sofia Marques, sofia.marques@research.fchampalimaud.org
Albino J. Oliveira-Maia, MD, MPH, PhD
About this study
Official title: Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment
Parkinson's Disease (PD) is a common and debilitating neurodegenerative disease. While medication can alleviate its symptoms, not all patients will adequately respond to medical therapy. For these cases, deep brain stimulation (DBS) has been used to improve symptoms and quality of life. Nevertheless, this approach is, in some cases, associated with incapacitating neuropsychiatric side-effects, including mood disturbances, such as DBS-induced mania. While this condition has important functional short- and long-term consequences for quality of life and prognosis, its pathophysiology is still poorly understood. In this project the investigators propose to conduct a retrospective and naturalistic study in PD patients in whom DBS stimulation resulted in mania or mixed state episode, to clarify if specific sociodemographic and clinical predictors, namely stimulation parameters and target locations, might be associated to the occurrence of this neuropsychiatric adverse event. Additionally, the investigators aim to clarify if the occurrence of DBS-induced mania results from the impact of specific stimulation parameters and/or target locations in functional connectivity networks. To explore this question, the investigators will use different neuroimaging analysis methods termed lesion topography analysis and lesion network mapping, in order to compute maps of the stimulated regions topography and the functional networks that are associated with DBS-mania, respectively. The data that will be analyzed in this project, including neuroimages, will be obtained retrospectively, by different Movement Disorders and Functional Surgery Groups in the context of Deep Brain Stimulation, and that has been collected according to their usual clinical practice.
Read the detailed description
Parkinson's Disease is the second most common neurodegenerative disorder, characterized by very debilitating motor and non-motor symptoms. While medication can alleviate the impact of this disease in patient's daily life, not all patients will respond adequately to treatment, its benefits may not be long-lasting and/or incapacitating side-effects may result. For these cases, DBS has been used to improve symptoms and quality of life. Nevertheless, this approach may have clinically significant side-effects. In fact, important neuropsychiatric adverse events can occur as a result of DBS stimulation, including DBS-induced mania. This is a debilitating mood disorder, frequently associated to a decrease in DBS efficacy due to the need to change/alter stimulation parameters or switch off the device entirely with the patient losing the benefits and the improving quality of life associated with the amelioration of his motor (but also non-motor) symptoms provided by DBS-stimulation. However, reliable predictors for its occurrence are lacking and its pathophysiology is still poorly understood. In this project, the investigators aim to clarify if there are specific DBS electrode locations and/or stimulation parameters associated to development of DBS-induced Mania while additionally determining other potential sociodemographic and clinical predictors. The investigators also aim to further explore if DBS-induced mania results from the impact of specific stimulation parameters and/or target locations in functional connectivity networks.
The investigators hypothesize that specific stimulation parameters and treatment targets associated with DBS-induced mania stimulation will impact particular subcortical brain regions, alongside other clinical and sociodemographic predictors. Additionally, the investigators hypothesize that such specific pattern of stimulation will be associated to specific dysfunctional brain connectivity networks. To address these hypotheses, the investigators propose three specific aims:
- To determine if there are specific DBS electrode location and/or stimulation parameters associated to development of DBS-induced Mania;
- To determine if there are specific sociodemographic and/or clinical predictors for the emergence of DBS-induced Mania;
- To explore if specific functional connectivity networks are associated to the DBS target location and/or stimulation parameters associated with Mania.
- Conditions
- Mania, Parkinson Disease
- Being tested
- No Intervention / Exposure
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, Mania
- Medical subject headings
- Mania, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention / ExposureOther
No intervention / exposure since this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| DBS-induced Mania Cohort | Patients diagnosed with Parkinson's Disease (PD) who were submitted to deep brain stimulation (DBS) surgery irrespective of its target and who developed a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters. Receives: Other: No Intervention / Exposure | |
| DBS Control Cohort | Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target and who did not develop DBS-induced mania. Receives: Other: No Intervention / Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topographic localization of volume of tissue activation (VTA) in DBS-induced mania
Differences in voxel-wise topographic localization of VTAs between DBS-induced mania in Parkinson's Disease (PD) and DBS PD controls. VTAs will be obtained using DBS electrodes locations and stimulation parameters.
Measured: From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months
Secondary outcomes (2)
Sociodemographic and/or clinical predictors of DBS-induced mania
Level of prediction of different models for DBS-induced mania in PD, when compared to DBS PD controls. Such models will explore different sociodemographic and/or clinical variables.
Measured: From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months
Connectivity profile of volume of tissue activation (VTA) in DBS-induced mania
Differences in voxel-wise connectivity profile of VTAs between DBS-induced mania in PD and DBS PD controls.
Measured: From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start25 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for ManiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albino Maia
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental, Centro Hospitalar De São João, E.P.E., Unidade Local de Saúde de Coimbra, EPE, Centro Hospitalar de Lisboa Central
- Responsible party
- Sponsor-investigator, Albino Maia, Fundacao Champalimaud
- Investigators
- Albino J. Oliveira-Maia, MD, MPH, PhD, Principal investigator, Champalimaud Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444907
- Sponsor's protocol ID
- BPD_DBS
- Acronym
- BPD_DBS
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Mhyre TR, Boyd JT, Hamill RW, Maguire-Zeiss KA. Parkinson's disease. Subcell Biochem. 2012;65:389-455. doi: 10.1007/978-94-007-5416-4_16.
PubMed 23225012Nutt JG, Wooten GF. Clinical practice. Diagnosis and initial management of Parkinson's disease. N Engl J Med. 2005 Sep 8;353(10):1021-7. doi: 10.1056/NEJMcp043908. No abstract available.
PubMed 16148287Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6. doi: 10.1159/000100803.
PubMed 3329873Siegfried J, Lippitz B. Bilateral chronic electrostimulation of ventroposterolateral pallidum: a new therapeutic approach for alleviating all parkinsonian symptoms. Neurosurgery. 1994 Dec;35(6):1126-9; discussion 1129-30. doi: 10.1227/00006123-199412000-00016.
PubMed 7885558Pollak P, Benabid AL, Gross C, Gao DM, Laurent A, Benazzouz A, Hoffmann D, Gentil M, Perret J. [Effects of the stimulation of the subthalamic nucleus in Parkinson disease]. Rev Neurol (Paris). 1993;149(3):175-6. French.
PubMed 8235208Deep-Brain Stimulation for Parkinson's Disease Study Group; Obeso JA, Olanow CW, Rodriguez-Oroz MC, Krack P, Kumar R, Lang AE. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001 Sep 27;345(13):956-63. doi: 10.1056/NEJMoa000827.
PubMed 11575287Mosley PE, Marsh R. The psychiatric and neuropsychiatric symptoms after subthalamic stimulation for Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2015 Winter;27(1):19-26. doi: 10.1176/appi.neuropsych.14040069.
PubMed 25716484Accolla EA, Pollo C. Mood Effects After Deep Brain Stimulation for Parkinson's Disease: An Update. Front Neurol. 2019 Jun 14;10:617. doi: 10.3389/fneur.2019.00617. eCollection 2019.
PubMed 31258509Mosley PE, Smith D, Coyne T, Silburn P, Breakspear M, Perry A. The site of stimulation moderates neuropsychiatric symptoms after subthalamic deep brain stimulation for Parkinson's disease. Neuroimage Clin. 2018 Mar 13;18:996-1006. doi: 10.1016/j.nicl.2018.03.009. eCollection 2018.
PubMed 29876284Boes AD, Prasad S, Liu H, Liu Q, Pascual-Leone A, Caviness VS Jr, Fox MD. Network localization of neurological symptoms from focal brain lesions. Brain. 2015 Oct;138(Pt 10):3061-75. doi: 10.1093/brain/awv228. Epub 2015 Aug 10.
PubMed 26264514Fox MD. Mapping Symptoms to Brain Networks with the Human Connectome. N Engl J Med. 2018 Dec 6;379(23):2237-2245. doi: 10.1056/NEJMra1706158. No abstract available.
PubMed 30575457Cotovio G, Talmasov D, Barahona-Correa JB, Hsu J, Senova S, Ribeiro R, Soussand L, Velosa A, Silva VCE, Rost N, Wu O, Cohen AL, Oliveira-Maia AJ, Fox MD. Mapping mania symptoms based on focal brain damage. J Clin Invest. 2020 Oct 1;130(10):5209-5222. doi: 10.1172/JCI136096.
PubMed 32831292Barahona-Correa JB, Cotovio G, Costa RM, Ribeiro R, Velosa A, Silva VCE, Sperber C, Karnath HO, Senova S, Oliveira-Maia AJ. Right-sided brain lesions predominate among patients with lesional mania: evidence from a systematic review and pooled lesion analysis. Transl Psychiatry. 2020 May 12;10(1):139. doi: 10.1038/s41398-020-0811-0.
PubMed 32398699van den Heuvel MP, Hulshoff Pol HE. Exploring the brain network: a review on resting-state fMRI functional connectivity. Eur Neuropsychopharmacol. 2010 Aug;20(8):519-34. doi: 10.1016/j.euroneuro.2010.03.008. Epub 2010 May 14.
PubMed 20471808Fox MD, Greicius M. Clinical applications of resting state functional connectivity. Front Syst Neurosci. 2010 Jun 17;4:19. doi: 10.3389/fnsys.2010.00019. eCollection 2010.
PubMed 20592951
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment
- ClinicalTrials.gov ID
- NCT05444907
- Acronym / sponsor ID
- BPD_DBS / BPD_DBS
- Conditions
- Mania, Parkinson Disease
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, Mania
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Albino MaiaUniversity, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Ocidental, Centro Hospitalar De São João, E.P.E., Unidade Local de Saúde de Coimbra, EPE, Centro Hospitalar de Lisboa Central
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jul 2022 (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.
Parkinson's Disease (PD) is a common and debilitating neurodegenerative disease. While medication can alleviate its symptoms, not all patients will adequately respond to medical therapy. For these cases, deep brain stimulation (DBS) has been used to improve symptoms and quality of life. Nevertheless, this approach is, in some cases, associated with incapacitating neuropsychiatric side-effects, including mood disturbances, such as DBS-induced mania. While this condition has important functional short- and long-term consequences for quality of life and prognosis, its pathophysiology is still poorly understood. In this project the investigators propose to conduct a retrospective and naturalistic study in PD patients in whom DBS stimulation resulted in mania or mixed state episode, to clarify if specific sociodemographic and clinical predictors, namely stimulation parameters and target locations, might be associated to the occurrence of this neuropsychiatric adverse event. Additionally, the investigators aim to clarify if the occurrence of DBS-induced mania results from the impact of specific stimulation parameters and/or target locations in functional connectivity networks. To explore this question, the investigators will use different neuroimaging analysis methods termed lesion topography analysis and lesion network mapping, in order to compute maps of the stimulated regions topography and the functional networks that are associated with DBS-mania, respectively. The data that will be analyzed in this project, including neuroimages, will be obtained retrospectively, by different Movement Disorders and Functional Surgery Groups in the context of Deep Brain Stimulation, and that has been collected according to their usual clinical practice.
Detailed description
Parkinson's Disease is the second most common neurodegenerative disorder, characterized by very debilitating motor and non-motor symptoms. While medication can alleviate the impact of this disease in patient's daily life, not all patients will respond adequately to treatment, its benefits may not be long-lasting and/or incapacitating side-effects may result. For these cases, DBS has been used to improve symptoms and quality of life. Nevertheless, this approach may have clinically significant side-effects. In fact, important neuropsychiatric adverse events can occur as a result of DBS stimulation, including DBS-induced mania. This is a debilitating mood disorder, frequently associated to a decrease in DBS efficacy due to the need to change/alter stimulation parameters or switch off the device entirely with the patient losing the benefits and the improving quality of life associated with the amelioration of his motor (but also non-motor) symptoms provided by DBS-stimulation. However, reliable predictors for its occurrence are lacking and its pathophysiology is still poorly understood. In this project, the investigators aim to clarify if there are specific DBS electrode locations and/or stimulation parameters associated to development of DBS-induced Mania while additionally determining other potential sociodemographic and clinical predictors. The investigators also aim to further explore if DBS-induced mania results from the impact of specific stimulation parameters and/or target locations in functional connectivity networks.
The investigators hypothesize that specific stimulation parameters and treatment targets associated with DBS-induced mania stimulation will impact particular subcortical brain regions, alongside other clinical and sociodemographic predictors. Additionally, the investigators hypothesize that such specific pattern of stimulation will be associated to specific dysfunctional brain connectivity networks. To address these hypotheses, the investigators propose three specific aims:
- To determine if there are specific DBS electrode location and/or stimulation parameters associated to development of DBS-induced Mania;
- To determine if there are specific sociodemographic and/or clinical predictors for the emergence of DBS-induced Mania;
- To explore if specific functional connectivity networks are associated to the DBS target location and/or stimulation parameters associated with Mania.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS-induced Mania Cohort | – | Other: No Intervention / ExposurePatients diagnosed with Parkinson's Disease (PD) who were submitted to deep brain stimulation (DBS) surgery irrespective of its target and who developed a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters. |
| DBS Control Cohort | – | Other: No Intervention / ExposurePatients diagnosed with PD who were submitted to DBS surgery irrespective of its target and who did not develop DBS-induced mania. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will be collected retrospectively from DBS surgery databases from different Movement Disorders and Functional Surgery Groups and further analyzed at the Champalimaud Neuropsychiatry Unit. Data collection will be conducted by each center independently under the approval of their respective Ethics Committees. The data that will be analyzed in this project, including neuroimages, has been collected according to the usual clinical practice of the Movement Disorders and Functional Surgery Groups.
Key inclusion criteria (3 listed)
- Age≥18-years-old;
- Patients diagnosed with PD who were submitted to DBS surgery irrespective of its target;
- Manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation, i.e., after switching on the device or changing modulation parameters.
Key exclusion criteria (4 listed)
- Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state before the age of 18
- Patients diagnosed with bipolar disorder, or manic episode, or mixed affective state, before DBS surgery.
- A control cohort will also be collected. These patients will also meet the aforementioned inclusion and exclusion criteria with the exception of not having presented a manic episode or mixed affective state diagnosed after surgery and associated to DBS modulation.
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 |
|---|---|---|
| No Intervention / ExposureNo intervention / exposure since this is an observational study | Other | DBS Control Cohort, DBS-induced Mania Cohort |
Primary outcome
Topographic localization of volume of tissue activation (VTA) in DBS-induced mania
Time frame: From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months
Differences in voxel-wise topographic localization of VTAs between DBS-induced mania in Parkinson's Disease (PD) and DBS PD controls. VTAs will be obtained using DBS electrodes locations and stimulation parameters.
2 secondary outcomes
Sociodemographic and/or clinical predictors of DBS-induced mania
Time frame: From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months
Connectivity profile of volume of tissue activation (VTA) in DBS-induced mania
Time frame: From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 23225012Mhyre TR, Boyd JT, Hamill RW, Maguire-Zeiss KA. Parkinson's disease. Subcell Biochem. 2012;65:389-455. doi: 10.1007/978-94-007-5416-4_16.
- Background: PubMed 16148287Nutt JG, Wooten GF. Clinical practice. Diagnosis and initial management of Parkinson's disease. N Engl J Med. 2005 Sep 8;353(10):1021-7. doi: 10.1056/NEJMcp043908. No abstract available.
- Background: PubMed 3329873Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6. doi: 10.1159/000100803.
- Background: PubMed 7885558Siegfried J, Lippitz B. Bilateral chronic electrostimulation of ventroposterolateral pallidum: a new therapeutic approach for alleviating all parkinsonian symptoms. Neurosurgery. 1994 Dec;35(6):1126-9; discussion 1129-30. doi: 10.1227/00006123-199412000-00016.
- Background: PubMed 8235208Pollak P, Benabid AL, Gross C, Gao DM, Laurent A, Benazzouz A, Hoffmann D, Gentil M, Perret J. [Effects of the stimulation of the subthalamic nucleus in Parkinson disease]. Rev Neurol (Paris). 1993;149(3):175-6. French.
- Background: PubMed 11575287Deep-Brain Stimulation for Parkinson's Disease Study Group; Obeso JA, Olanow CW, Rodriguez-Oroz MC, Krack P, Kumar R, Lang AE. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001 Sep 27;345(13):956-63. doi: 10.1056/NEJMoa000827.
- Background: PubMed 25716484Mosley PE, Marsh R. The psychiatric and neuropsychiatric symptoms after subthalamic stimulation for Parkinson's disease. J Neuropsychiatry Clin Neurosci. 2015 Winter;27(1):19-26. doi: 10.1176/appi.neuropsych.14040069.
- Background: PubMed 31258509Accolla EA, Pollo C. Mood Effects After Deep Brain Stimulation for Parkinson's Disease: An Update. Front Neurol. 2019 Jun 14;10:617. doi: 10.3389/fneur.2019.00617. eCollection 2019.
- Background: PubMed 29876284Mosley PE, Smith D, Coyne T, Silburn P, Breakspear M, Perry A. The site of stimulation moderates neuropsychiatric symptoms after subthalamic deep brain stimulation for Parkinson's disease. Neuroimage Clin. 2018 Mar 13;18:996-1006. doi: 10.1016/j.nicl.2018.03.009. eCollection 2018.
- Background: PubMed 26264514Boes AD, Prasad S, Liu H, Liu Q, Pascual-Leone A, Caviness VS Jr, Fox MD. Network localization of neurological symptoms from focal brain lesions. Brain. 2015 Oct;138(Pt 10):3061-75. doi: 10.1093/brain/awv228. Epub 2015 Aug 10.
- Background: PubMed 30575457Fox MD. Mapping Symptoms to Brain Networks with the Human Connectome. N Engl J Med. 2018 Dec 6;379(23):2237-2245. doi: 10.1056/NEJMra1706158. No abstract available.
- Background: PubMed 32831292Cotovio G, Talmasov D, Barahona-Correa JB, Hsu J, Senova S, Ribeiro R, Soussand L, Velosa A, Silva VCE, Rost N, Wu O, Cohen AL, Oliveira-Maia AJ, Fox MD. Mapping mania symptoms based on focal brain damage. J Clin Invest. 2020 Oct 1;130(10):5209-5222. doi: 10.1172/JCI136096.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
Related trials for Mania
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
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.
Albino J. Oliveira-Maia, MD, MPH, PhD principal investigator
Champalimaud Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mania and Parkinson Disease, run by Albino Maia at 1 site in Portugal.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Feb 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Marques (+351 210 480 048 ext. 4153, sofia.marques@research.fchampalimaud.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Topographic localization of volume of tissue activation (VTA) in DBS-induced mania (time frame: From DBS parametres change until the date of first documented manic symptoms, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05444907, which also lists 22 linked publications.
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 26 Feb 2025.