Obsessive-Compulsive DisorderNCT05964998
Pilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder
A study testing transcranial direct current stimulation in people with Obsessive-Compulsive Disorder, run by Rogers Behavioral Health at 1 site in United States.
Trial summary
This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS) versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), on patient-reported outcomes. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 11 Dec 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of Obsessive-Compulsive Disorder (OCD)
- Resident of state of Wisconsin
- Enrolled in OCD Intensive Outpatient Program (IOP) at Rogers Behavioral Health in Oconomowoc, WI
- Ability to communicate effectively using written and spoken English
Who cannot join
- Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
- Currently taking medication that reduces seizure threshold (e.g., clomipramine)
- Cranial pathologies (e.g., holes, plates)
- History of seizure or black-out concussion
- Pregnancy
- Previous treatment at Rogers Behavioral Health
Trial locations and contacts
1 site in 1 country.
United States1 site
Rogers Behavioral Health
Oconomowoc, Wisconsin, 53066
About this study
Official title: Investigating Non-invasive Brain Stimulation to Enhance CBT in Intensive Treatment-seeking Patients With OCD
This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS) versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator hypothesize that patients who receive active stimulation will experience greater improvement in OCD symptoms than those who receive sham stimulation.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- transcranial direct current stimulation, Sham transcranial direct current stimulation
- Keywords
- Obsessive-Compulsive Disorder, OCD, transcranial direct current stimulation, tDCS, Cognitive Behavior Therapy, CBT
- 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.
transcranial direct current stimulationDevice
Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes
Sham transcranial direct current stimulationDevice
Current will increase up to 1.5 milliamps within 30 seconds and then decrease back down over the next 30 seconds to 0 milliamps; subjects will received 0 milliamps for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Not described Receives: Device: transcranial direct current stimulation |
| Sham stimulation | Sham comparator | Not described Receives: Device: Sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge
Measured: Up to 12 weeks
Change in Quick Inventory of Depressive Symptomology from admission to discharge
Measured: Up to 12 weeks
Secondary outcomes (5)
Number of treatment days between admission and discharge
Measured: Up to 12 weeks
Change in Obsessive-Compulsive Inventory-Revised from admission to discharge
Measured: Up to 12 weeks
Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge
Measured: Up to 12 weeks
Change in Intolerance of uncertainty scale from admission to discharge
Measured: Up to 12 weeks
Change in Subjective units of distress from admission to discharge
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start18 Mar 2024
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Why it stopped: Unable to find patients willing to consent; declined for various reasoning: e.g., time commitment for the study, concerns about electrode gel in the hair, and concerns about potentially being randomized to a control group.
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
- Participants randomized to either active tDCS stimulation or sham.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rogers Behavioral Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley C Riemann, PhD, Principal investigator, Rogers Behavioral Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964998
- Sponsor's protocol ID
- 22-ROGE-103
- Status last verified
- Dec 2024
- First submitted
- 3 Apr 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Non-invasive Brain Stimulation to Enhance CBT in Intensive Treatment-seeking Patients With OCD
- ClinicalTrials.gov ID
- NCT05964998
- Acronym / sponsor ID
- 22-ROGE-103
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, OCD, transcranial direct current stimulation, tDCS, Cognitive Behavior Therapy, CBT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to find patients willing to consent; declined for various reasoning: e.g., time commitment for the study, concerns about electrode gel in the hair, and concerns about potentially being randomized to a control group.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rogers Behavioral HealthUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 28 Jul 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.
This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS) versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator hypothesize that patients who receive active stimulation will experience greater improvement in OCD symptoms than those who receive sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants randomized to either active tDCS stimulation or sham.
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: transcranial direct current stimulation |
| Sham stimulation | Sham comparator | Device: Sham transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary diagnosis of Obsessive-Compulsive Disorder (OCD)
- Resident of state of Wisconsin
- Enrolled in OCD Intensive Outpatient Program (IOP) at Rogers Behavioral Health in Oconomowoc, WI
- Ability to communicate effectively using written and spoken English
Key exclusion criteria (6 listed)
- Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
- Currently taking medication that reduces seizure threshold (e.g., clomipramine)
- Cranial pathologies (e.g., holes, plates)
- History of seizure or black-out concussion
- Pregnancy
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 direct current stimulationCurrent will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes | Device | Active stimulation |
| Sham transcranial direct current stimulationCurrent will increase up to 1.5 milliamps within 30 seconds and then decrease back down over the next 30 seconds to 0 milliamps; subjects will received 0 milliamps for 20 minutes | Device | Sham stimulation |
Primary outcome
Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge
Time frame: Up to 12 weeks
Change in Quick Inventory of Depressive Symptomology from admission to discharge
Time frame: Up to 12 weeks
5 secondary outcomes
Number of treatment days between admission and discharge
Time frame: Up to 12 weeks
Change in Obsessive-Compulsive Inventory-Revised from admission to discharge
Time frame: Up to 12 weeks
Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge
Time frame: Up to 12 weeks
Change in Intolerance of uncertainty scale from admission to discharge
Time frame: Up to 12 weeks
Change in Subjective units of distress from admission to discharge
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- 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.
Bradley C Riemann, PhD principal investigator
Rogers Behavioral Health
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 direct current stimulation in people with Obsessive-Compulsive Disorder, run by Rogers Behavioral Health 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 Dec 2024. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge (time frame: Up to 12 weeks). The study lists 2 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 16 Dec 2024.