What this study is
This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal cervical dystonia. Previous research demonstrated that individualized TMS improved writing behavior in focal hand dystonia after one session. In this study, we aim to expand the application on TMS on focal cervical dystonia. The current study administers six sessions of TMS separated by five rest blocks, all in a single day and combined with a medication called trihexyphenidyl given 30 minutes before the TMS session. This approach is called "anticholinergic enhanced accelerated TMS The research involves 8 in-person visits and 3 remote visits over 28 weeks. The effect of TMS will be assessed using functional MRI brain scans and behavioral measurements. Participants who are interested in enrolling in the TMS study to assess their potential presurgical response to DBS will only receive the active TMS session combined with trihexyphenidyl medication. After active TMS + trihexyphenidyl medication, participants will be followed for 3-5months to assess their brain and behavior response to TMS. Following clinical care DBS, participants will be followed for three additional research visits. The three visits will be performed at 1 month, 3 months and 6-9 months. During the post-DBS research visits, participants will complete behavioral assay and physiological assay to evaluate their neck movements and muscles. At 3 month or 6-9 month visit, the post-DBS participants will also undergo fMRI with the DBS device in off mode setting.
The risk of TMS includes seizures; the potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in cervical dystonia, paving the way for further advancements in clinical therapy for this condition.
What's being tested
- Transcranial Magnetic Stimulation (TMS)
Intervention · DEVICE
Participants will experience two accelerated transcranial magnetic stimulation (TMS) sessions, with 12 week (three-months) gap between each session.
- Placebo
Intervention · DRUG
- trihexyphenidyl 10mg
Intervention · DRUG
Both Placebo and trihexyphenidyl 10mg
Given 30 minutes before the TMS session.
Study details
- Official title
- Functional Magnetic Resonance Imaging (fMRI)-Guided Individualized Transcranial Magnetic Stimulation (TMS) for Cervical Dystonia
- Sponsor
- Duke University
- Conditions
- Isolated Cervical Dystonia
- Enrolling
- 50 people
- Starts
- 2024-12-17
- Est. completion
- 2029-07-01
- Design
- Triple-blind, randomized, crossover, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 18yrs and older
- Diagnosed with isolated cervical dystonia by Neurologist
- Must be able to sign an informed consent
- Must be literate
You can't join if
- Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
- History of seizure disorder
- Concomitant medications known to decrease seizure threshold
- Illicit drug use
- No TMS therapy for another indication within one month of this research study
- Botulinum toxin injections within 3 months of the research study
- Medications used for symptom treatment of dystonia including anticholinergic, benzodiazepines, and muscle relaxants among others within one month of the study
- No physical or occupational therapy of the neck within one month of the study
- Any contraindications to MRI or TMS Inclusion criteria for cervical dystonia subjects considering DBS
- 18yrs and older
- Diagnosed with cervical dystonia by a Neurologist
- Must be able to sign informed consent
- Must be literate
- On no medications or one medication to treat symptoms of dystonia for a minimum of one month prior to study participation Exclusion criteria for cervical dystonia subjects considering DBS
- Other neurological movement disorders diagnoses including Parkinsonism, or essential tremor
- Botulinum toxin injections within 3 months of research study
- More than two medications used for symptom treatment of dystonia including anticholinergic, benzodiazepines, and muscle relaxants among others within one month of the study
- Contraindications to MRI or TMS
- A history of seizures and anti-seizure medications by review of medical records
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDuke University Health System
Durham, North Carolina, United States
Study team
Sponsor
Duke University
Study ID Pro00114549
Principal investigator
Noreen Bukhari-Parlakturk, MD PhD
Duke Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.