Obsessive-Compulsive DisorderNCT06049706
Priming in Repetitive Transcranial Magnetic Stimulation in the Treatment of Obsessive Compulsive Disorder
A study testing Active Priming in people with Obsessive-Compulsive Disorder, run by Suellen Andrade at 1 site in Brazil.
Trial summary
Obsessive Compulsive Disorder results in high social impact, affecting quality of life and tending to a chronic course. A considerable proportion of patients, up tp 60%, remain with symptoms even thought treatment is administrated. Therefore, new therapeutic interventions are highly necessary. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Active Priming
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 17 May 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being right-handed;
- Age between 18 and 60;
- Diagnose of OCD according to DSM-5;
- Score in YBOCS between 16 and 23;
- No change in dose prescription in the previous 3 months;
- Signature of informed consent term.
Who cannot join
- Being pregnant;
- Having cognitive deficit;
- Diagnose of drug use disorder;
- In current psychotherapy (or interrupted in less than 3 months);
- Diagnose of severe Major Depression;
- Risk of suicide;
- Patients with metallic implants in the brain;
- Epileptics.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Paraíba,Department of Psychology
João Pessoa, Paraíba, 58051-900
Suellen Andrade, Phd, 986046032 ext. 5583, suellenadrade@gmail.com
Raissa Fonseca, 999501512 ext. 5583, raissaalexandria@gmail.com
About this study
Official title: Priming in Repetitive Transcranial Magnetic Stimulation (TMSr) in the Adjuvant Treatment of Obsessive Compulsive Disorder (OCD)
Obsessive Compulsive Disorder results in high social impact, affecting quality of life and tending to a chronic course. A considerable proportion of patients, up tp 60%, remain with symptoms even thought treatment is administrated. Therefore, new therapeutic interventions are highly necessary. In this context, repetitive transcranial magnetic stimulation has been used for several psychiatric conditions, including OCD treatment. Moreover, many approaches of neuromodulation seem to reach a better result when used a priming stimulation. In an attemp to optimize particularities of the thecnique applied, this study aims to assess if a priming stimulation with rTMS might impact in a better outcome when compared with rTMS without previous stimulation.
Read the detailed description
This is a randomized, double-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 16 patients, totaling 50 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
In the active priming, the parameters are: frequency of 6 Hz for 10 minutos, 80% do Motor Threshold (MT), 20 trains of 5 seconds, with intertrain interval of 25 seconds, a total f 600 stimulations. The group of innactive priming will have the same parameters, but without active atimulation. After this previous stimulation, all participants will receive the main stimulation: 10 sessions of rTMS, each lasting around 20 minutes, for 5 days a week, during two consecutive weeks.
The target area will be the supplementary motor area. Primary outcome will be assessed by change in Yale-Brown Obsessive Compulsive Scale scores. As secondary outcomes, it will be used HAM-A for anxiety, HAM-D for depression, CGI-S for global clinical impression and SF-36 for quality of life.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Active Priming, Sham Priming
- Keywords
- priming, supplementary motor area, obsessive-compulsive disorder, transcranial magnetic stimulation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PrimingDevice
Also called Priming TMSr
It will be applied an active priming stimulation in the supplementary motor area previously to the main stimulation to analyse if that will enhance the response to TMSr, compared to inactive priming.
To apply intervention, it will be used Repetitive Transcranial Magnetic Stimulation Model MagPro R20 (MagVenture Brazil, country Brazil) and the butterfly coil MCF-B70 (MagVenture Brazil, country Brazil).
Each session will last around 20 minutes, and it will be used a 1 Hz frequency, 1200 pulses/day, with 100% of Motor Threshold, once a day, 5 days a week, for two consecutive weeks.
Active Priming group participants will be previously stimulated for 10 minutes (20 trains of 5 seconds with intertrain interval of 25 seconds), with 6Hz frequency over Supplementary Motor Area, receiving 80% of Motor Threshold, with a total of 600 stimulations.
Sham PrimingDevice
Sham Priming group participants will receive a placebo stimulation for ten minutes, with the same parameters and target area as the active group, they will hear the equipament noise and might feel any sensation in the scalp, but there won't be effective stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active Priming (TMSr) | Experimental | To apply intervention, it will be used Repetitive Transcranial Magnetic Stimulation Model MagPro R20 (MagVenture Brazil, country Brazil) and the butterfly coil MCF-B70 (MagVenture Brazil, country Brazil).
Each session will last around 20 minutes, and it will be used a 1 Hz frequency, 1200 pulses/day, with 100% of Motor Threshold, once a day, 5 days a week, for two consecutive weeks.
Active Priming group participants will be previously stimulated for 10 minutes (20 trains of 5 seconds with intertrain interval of 25 seconds), with 6Hz frequency over Supplementary Motor Area, receiving 80% of Motor Threshold, with a total of 600 stimulations. Receives: Device: Active Priming |
| Sham Priming | Sham comparator | Sham Priming group participants will receive a placebo stimulation for ten minutes, with the same parameters and target area as the active group, they will hear the equipament noise and might feel any sensation in the scalp, but there won't be effective stimulation. Receives: Device: Sham Priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale-Brown Obsessive Compulsive Scale
It's a 10-item-scale that evaluates the symptoms' severity of Obsessive Compulsive Disorder. Includes five dimensions that evaluate obsessions and compulsions. The ten itens score from 0 (no symptom) to 4 (extreme symptoms), possibly scoring from 0-20 in obsessions' severity, 0-20 in compulsions' severity, with a total 0-40. YBOCS is considered gold standard in evaluating the severity of OCD symptoms.
Measured: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Secondary outcomes (4)
Change in Hamilton Scale for Depression
It's a multidimensional scale which allows evaluating depression symptoms. It will be chosen the variant of 17-item, given that the 21-item doesn't add relevant information for our purposes.
Measured: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Hamilton Scale for Anxiety
A 14-item scale that evaluates both physical and psychological aspects of anxiety
Measured: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Clinical Global Impression - Scale
It's divided into two sub-scales, one that evaluates the severity of disease and one that evaluates clinical improvements. Scores from 1 to 7 (in which 7 refers to worse severity or worse improvement).
Measured: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Medical Outcomes Study 36 - Item Short Form Health Survey
Evaluates quality of life and takes into account 36 items, across 8 dimensions.
Measured: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start17 May 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Participants will be divided into 02 groups, each with 16 patients, totaling 32 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered into the study through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suellen Andrade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suellen Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049706
- Sponsor's protocol ID
- PrimingTMS/OCD
- Status last verified
- Sep 2023
- First submitted
- 14 Jul 2022
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming in Repetitive Transcranial Magnetic Stimulation (TMSr) in the Adjuvant Treatment of Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT06049706
- Acronym / sponsor ID
- PrimingTMS/OCD
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- priming, supplementary motor area, obsessive-compulsive disorder, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Suellen AndradeUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 22 Sep 2023 (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.
Obsessive Compulsive Disorder results in high social impact, affecting quality of life and tending to a chronic course. A considerable proportion of patients, up tp 60%, remain with symptoms even thought treatment is administrated. Therefore, new therapeutic interventions are highly necessary. In this context, repetitive transcranial magnetic stimulation has been used for several psychiatric conditions, including OCD treatment. Moreover, many approaches of neuromodulation seem to reach a better result when used a priming stimulation. In an attemp to optimize particularities of the thecnique applied, this study aims to assess if a priming stimulation with rTMS might impact in a better outcome when compared with rTMS without previous stimulation.
Detailed description
This is a randomized, double-blind, sham-controlled clinical trial. Neuropsychological tests and a sociodemographic and clinical questionnaire will be used to assess and characterize the subjects. Participants captured by the Laboratory of Studies in Aging and Neuroscience at the Federal University of Paraíba will be divided into 02 groups, each with 16 patients, totaling 50 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
In the active priming, the parameters are: frequency of 6 Hz for 10 minutos, 80% do Motor Threshold (MT), 20 trains of 5 seconds, with intertrain interval of 25 seconds, a total f 600 stimulations. The group of innactive priming will have the same parameters, but without active atimulation. After this previous stimulation, all participants will receive the main stimulation: 10 sessions of rTMS, each lasting around 20 minutes, for 5 days a week, during two consecutive weeks.
The target area will be the supplementary motor area. Primary outcome will be assessed by change in Yale-Brown Obsessive Compulsive Scale scores. As secondary outcomes, it will be used HAM-A for anxiety, HAM-D for depression, CGI-S for global clinical impression and SF-36 for quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment Participants will be divided into 02 groups, each with 16 patients, totaling 32 volunteers: Active - participants who will receive real priming stimulation; Sham - participants who will receive simulated priming stimulation. Participants entered into the study through the eligibility criteria will be randomly allocated in a simple way, at a rate of 1:1.
| Arm | Type | Receives |
|---|---|---|
| Active Priming (TMSr) | Experimental | Device: Active PrimingTo apply intervention, it will be used Repetitive Transcranial Magnetic Stimulation Model MagPro R20 (MagVenture Brazil, country Brazil) and the butterfly coil MCF-B70 (MagVenture Brazil, country Brazil). Each session will last around 20 minutes, and it will be used a 1 Hz frequency, 1200 pulses/day, with 100% of Motor Threshold, once a day, 5 days a week, for two consecutive weeks. Active Priming group participants will be previously stimulated for 10 minutes (20 trains of 5 seconds with intertrain interval of 25 seconds), with 6Hz frequency over Supplementary Motor Area, receiving 80% of Motor Threshold, with a total of 600 stimulations. |
| Sham Priming | Sham comparator | Device: Sham PrimingSham Priming group participants will receive a placebo stimulation for ten minutes, with the same parameters and target area as the active group, they will hear the equipament noise and might feel any sensation in the scalp, but there won't be effective stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being right-handed;
- Age between 18 and 60;
- Diagnose of OCD according to DSM-5;
- Score in YBOCS between 16 and 23;
- No change in dose prescription in the previous 3 months;
Key exclusion criteria (8 listed)
- Being pregnant;
- Having cognitive deficit;
- Diagnose of drug use disorder;
- In current psychotherapy (or interrupted in less than 3 months);
- Diagnose of severe Major Depression;
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 |
|---|---|---|
| Active PrimingAlso: Priming TMSrIt will be applied an active priming stimulation in the supplementary motor area previously to the main stimulation to analyse if that will enhance the response to TMSr, compared to inactive priming. To apply intervention, it will be used Repetitive Transcranial Magnetic Stimulation Model MagPro R20 (MagVenture Brazil, country Brazil) and the butterfly coil MCF-B70 (MagVenture Brazil, country Brazil). Each session will last around 20 minutes, and it will be used a 1 Hz frequency, 1200 pulses/day, with 100% of Motor Threshold, once a day, 5 days a week, for two consecutive weeks. Active Priming group participants will be previously stimulated for 10 minutes (20 trains of 5 seconds with intertrain interval of 25 seconds), with 6Hz frequency over Supplementary Motor Area, receiving 80% of Motor Threshold, with a total of 600 stimulations. | Device | Active Priming (TMSr) |
| Sham PrimingSham Priming group participants will receive a placebo stimulation for ten minutes, with the same parameters and target area as the active group, they will hear the equipament noise and might feel any sensation in the scalp, but there won't be effective stimulation. | Device | Sham Priming |
Primary outcome
Change in Yale-Brown Obsessive Compulsive Scale
Time frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
It's a 10-item-scale that evaluates the symptoms' severity of Obsessive Compulsive Disorder. Includes five dimensions that evaluate obsessions and compulsions. The ten itens score from 0 (no symptom) to 4 (extreme symptoms), possibly scoring from 0-20 in obsessions' severity, 0-20 in compulsions' severity, with a total 0-40. YBOCS is considered gold standard in evaluating the severity of OCD symptoms.
4 secondary outcomes
Change in Hamilton Scale for Depression
Time frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Hamilton Scale for Anxiety
Time frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Clinical Global Impression - Scale
Time frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Change in Medical Outcomes Study 36 - Item Short Form Health Survey
Time frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- 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.
Suellen Andrade principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Priming in people with Obsessive-Compulsive Disorder, run by Suellen Andrade at 1 site in Brazil.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen Andrade (986046032 ext. 55 83, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale-Brown Obsessive Compulsive Scale (time frame: From date of randomization (1 week before intervention beginning) and up to 8 weeks). 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 22 Sep 2023.