Neuromodulation Therapy for Task-Specific Dystonia

NCT06422104 | Completed Results DMC FDA Device

• 1 other identifier: Pro00094131
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.

Conditions

Isolated Focal Hand Dystonia

Outcome Measures

Primary Outcomes (1)

• Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions

  Pre-TMS and post-TMS session (each session is approximately 45 minutes)

Secondary Outcomes (3)

• Safety, as Measured by TMS Acute Side Effects

  During TMS session (each session is approximately 45 minutes)

• Change in Peak Accelerations Behavior (Calculated by Taking the Change in Peak Accelerations From Behavior Performed Before and After Each TMS Visit).

  Pre-TMS and post-TMS session (each session is approximately 45 minutes)

• Brain Connectivity Between Superior Parietal Cortex to Right Cerebellum VIII

  Post-TMS session (each session is approximately 45 minutes)

Study Arms (3)

10 Hz rTMS to premotor cortex

ACTIVE COMPARATOR

10 Hz rTMS to premotor cortex

Device: Repetitive transcranial magnetic stimulation

10 Hz rTMS to primary somatosensory cortex

ACTIVE COMPARATOR

10 Hz rTMS to primary somatosensory cortex

Device: Repetitive transcranial magnetic stimulation

0.7 Hz rTMS to premotor cortex

ACTIVE COMPARATOR

0.7 Hz rTMS to premotor cortex

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

10 Hz repetitive TMS will be delivered for 20 minutes per session and 0.7 Hz for 20 minutes per session

0.7 Hz rTMS to premotor cortex; 10 Hz rTMS to premotor cortex; 10 Hz rTMS to primary somatosensory cortex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Control Participants:
• yrs and older
• Left or Right hand dominance
• Age-matched to Focal Hand dystonia patients
• Must be able to sign informed consent
• Must be literate
• Focal Hand dystonia Patients:
• yrs and older
• Left or Right hand dominance
• Diagnosed with Writer's Cramp dystonia in left or right hand
• Must be able to sign informed consent
• Must be literate

You may not qualify if:

• Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):
• Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
• Botulinum toxin injections within 3 months of research study
• Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study
• No physical or occupational therapy of the upper extremities
• Any contraindications to MRI (ie: metal in body or implanted medical devices, etc)
• Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion

Sponsors & Collaborators

• Duke University: lead
• Doris Duke Charitable Foundation: collaborator
• Dystonia Coalition: collaborator
• Dystonia Study Group: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

• Mulcahey PJ, Peterchev AV, Calakos N, Bukhari-Parlakturk N. Transcranial magnetic stimulation: the road to clinical therapy for dystonia. Dystonia. 2023 August; 2.

  BACKGROUND

• Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Organization of Human Brain Mapping Conference. Montreal, Canada. July 22-26, 2023. virtual poster presentation.

  BACKGROUND

• Bukhari-Parlakturk N, Mulcahey PJ, Lutz M, Ghazi R, Huang Z, Dannhauer M, Simsek Z, Groves S, Lipp M, Fei M, Tran T, Wood E, Beynel L, Scott B, Termsarasab P, Petty C, Al-Khalidi HR, Voyvodic J, Appelbaum LG, Davis S, Michael A, Peterchev AV, Calakos N. Functional MRI-guided personalized TMS decreases basal ganglia activity and improves focal hand dystonia. International Dystonia Symposium. Dublin, Ireland. June 1-3, 2023. poster presentation.

  BACKGROUND

• Bukhari-Parlakturk N, Lutz MW, Al-Khalidi HR, Unnithan S, Wang JE, Scott B, Termsarasab P, Appelbaum LG, Calakos N. Suitability of Automated Writing Measures for Clinical Trial Outcome in Writer's Cramp. Mov Disord. 2023 Jan;38(1):123-132. doi: 10.1002/mds.29237. Epub 2022 Oct 13.

  PMID: 36226903 BACKGROUND

• Dannhauer M, Huang Z, Beynel L, Wood E, Bukhari-Parlakturk N, Peterchev AV. TAP: targeting and analysis pipeline for optimization and verification of coil placement in transcranial magnetic stimulation. J Neural Eng. 2022 Apr 21;19(2):10.1088/1741-2552/ac63a4. doi: 10.1088/1741-2552/ac63a4.

  PMID: 35377345 BACKGROUND

• Bukhari-Parlakturk N, Mulcahey PJ, Lutz MW, Ghazi R, Huang Z, Dannhauer M, Termsarasab P, Scott B, Simsek ZB, Groves S, Lipp M, Fei M, Tran TK, Wood E, Beynel L, Petty C, Voyvodic JT, Appelbaum LG, Al-Khalidi HR, Davis SW, Michael AM, Peterchev AV, Calakos N. Motor network reorganization associated with rTMS-induced writing improvement in writer's cramp dystonia. Brain Stimul. 2025 Mar-Apr;18(2):198-210. doi: 10.1016/j.brs.2025.02.005. Epub 2025 Feb 7.

  PMID: 39924101 RESULT

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Noreen Bukhari-Parlakturk, MD PhD
• Organization: Duke University Medical Center

noreen.bukhari@duke.edu

(919) 684-8704

Study Officials

• Noreen Bukhari-Parlakturk, MD PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The TMS intensity and cortical location delivered at each TMS visit will be masked
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind cross-over design with participants receiving TMS at two cortical locations.

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 20, 2024
• Study Start: August 23, 2018
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: April 13, 2026
• Results First Posted: April 13, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)