---
title: Prevent mania after brain stimulation
nct_id: NCT05444907
status: RECRUITING
sponsor: Albino Maia
study_type: OBSERVATIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT05444907"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05444907"
last_fetched: "2026-05-10T14:03:44.016Z"
source: "Parkinson's Pathways (curated)"
---
# Prevent mania after brain stimulation

**Goal (in five words):** Prevent mania after brain stimulation

**Official Title:** Understanding Deep Brain Stimulation-induced Mania: Finding Potential Predictors to Optimize Treatment

**Trial ID:** [NCT05444907](https://clinicaltrials.gov/study/NCT05444907)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Sponsor:** Albino Maia
- **Target Enrollment:** 100 participants
- **Start Date:** 2021-05-25
- **Completion Date:** 2025-12-31
- **Conditions:** Mania, Parkinson Disease
- **Interventions:** No Intervention / Exposure
- **Intervention Types:** OTHER

## Summary For Families

The goal is to find clinical and stimulation-related factors that predict mania after deep brain stimulation, so clinicians can pick targets and programming that lower that risk. The team will compare people with Parkinson's who developed a manic or mixed affective state after the device was switched on or its settings were changed to similar DBS-treated patients who did not, looking at stimulation target and parameters, medications, and clinical history; DBS works by sending electrical pulses to specific brain areas to improve motor symptoms, but those pulses can sometimes activate nearby mood circuits and trigger mania, and it may change how much levodopa someone needs. Adults 18 and older who had DBS for Parkinson's are eligible, with one group having a post-activation or post-programming manic episode and a control group without such episodes, and anyone with bipolar disorder or a history of mania before surgery or before age 18 is excluded.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full Criteria

```
DBS-induced mania cohort:

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Locations (1)

- Champalimaud Foundation, Lisbon, Portugal _(38.7251, -9.1498)_
  - Sofia Marques — (CONTACT) — sofia.marques@research.fchampalimaud.org
  - Albino J. Oliveira-Maia, MD, MPH, PhD — (PRINCIPAL_INVESTIGATOR)
  - Gonçalo Cotovio, MD — (SUB_INVESTIGATOR)
  - Francisco Viana — (SUB_INVESTIGATOR)
  - Sara Penedos, MD — (SUB_INVESTIGATOR)
  - J. Bernardo Barahona-Correa, MD, PhD — (SUB_INVESTIGATOR)

## Central Contacts

- Sofia Marques — (CONTACT) — +351 210 480 048 — sofia.marques@research.fchampalimaud.org

---

*Canonical: https://parkinsonspathways.com/trial/NCT05444907*  
*HTML version: https://parkinsonspathways.com/trial/NCT05444907*  
*Source data: https://clinicaltrials.gov/study/NCT05444907*